Role Profile: Technical PMO Manager Job Title: Technical PMO Manager Location: Warrington Reports To: Chief Digital and Information Officer (CDIO) Salary: £55,000 to £60,000 (plus car) Purpose of Role The Technical PMO Manager is responsible for the strategic oversight and management of the Project Management Office (PMO) with a focus on technical projects. This role ensures the successful delivery of key IT initiatives by implementing best practices, optimising resource allocation, and maintaining alignment with business objectives. Key Responsibilities Technical Portfolio Managemen t: Ø Develop and maintain the IT project portfolio, ensuring alignment with the organisation s strategic goals and technical requirements Ø Prioritise technical projects based on business value, resource availability, and risk assessment Ø Provide regular portfolio status updates to senior management and stakeholders Governance and Standards : Ø Establish and enforce project management standards, methodologies, and best practices (e.g., Agile, Waterfall, PRINCE2) tailored to technical projects Ø Develop and maintain PMO policies, procedures, and templates to ensure consistency and quality across technical projects Ø Conduct regular audits and reviews to ensure compliance with established standards Resource and Capacity Management : Ø Allocate technical resources effectively across projects, ensuring optimal utilisation and balancing workloads Ø Monitor resource capacity and demand, adjusting as necessary to meet project needs Ø Collaborate with HR and department heads to address resource gaps and develop talent pipelines Risk and Issue Management : Ø Identify, assess, and mitigate risks associated with technical projects, ensuring proactive issue resolution Ø Develop and maintain a risk management framework, including risk registers and mitigation plans Ø Facilitate risk workshops and training sessions for project teams Performance Monitoring and Reporting : Ø Track and report on project performance metrics, including scope, schedule, budget, and quality Ø Develop and maintain dashboards and reports to provide real-time visibility into project status Ø Conduct post-project reviews and lessons learned sessions to identify areas for improvement Stakeholder Engagement and Communication : Ø Collaborate with business leaders and project managers to ensure stakeholder needs are met and expectations are managed Ø Facilitate regular communication and reporting to stakeholders, including status updates, risk assessments, and performance metrics Ø Act as a liaison between the IT department and other business units, fostering a collaborative environment Continuous Improvement : Ø Drive improvements in project management processes, tools, and techniques to enhance efficiency and effectiveness Ø Stay current with industry trends and best practices, incorporating relevant innovations into the PMO Ø Lead initiatives to enhance project management maturity within the organisation Training and Development : Ø Provide training and support to project managers and teams, fostering a culture of excellence in project management Ø Develop and deliver training programs on project management methodologies, tools, and best practices Ø Mentor and coach project managers, helping them to develop their skills and advance their careers Skills and Qualifications Education : Bachelor s degree in information technology, Computer Science, Engineering, Business Administration, Project Management, or relevant experience Relevant certifications (e.g., PMP, PRINCE2, Agile) are highly desirable Experience : Extensive experience in project management, with a proven track record of managing complex technical IT projects and leading a PMO Demonstrated experience in portfolio management, governance, and resource management. Technical Expertise : Strong technical background with knowledge of IT infrastructure, software development, and systems integration Proficiency in project management software and tools (e.g., MS Project, JIRA, Trello) Leadership : Strong leadership and team management skills, with the ability to inspire and motivate project teams Experience in leading cross-functional teams and managing multiple projects simultaneously Communication : Excellent communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels Strong presentation and facilitation skills, with the ability to convey complex technical information clearly and concisely Analytical Skills : Strong analytical and problem-solving skills, with the ability to make data-driven decisions Ability to analyse technical requirements and translate them into actionable project plans. Organisational Skills : Exceptional organisational and multitasking abilities, with a keen attention to detail Ability to manage competing priorities and meet deadlines in a fast-paced environment. Adaptability : Ability to thrive in a dynamic environment and adapt to changing circumstances Resilient and able to maintain composure under pressure Personal Attributes : Proactive: Takes initiative and is able to anticipate and address project challenges Collaborative : Works effectively with diverse teams and stakeholders, fostering a collaborative environment Strategic Thinker : Able to see the big picture and align project outcomes with business goals Resilient : Maintains composure and effectiveness under pressure, adapting to changing circumstances Key Performance Indicators (KPIs) Ø Successful delivery of technical IT projects (on time, within budget, meeting requirements) Ø Alignment of project outcomes with business objectives Ø Stakeholder satisfaction and engagement levels Ø Efficiency and effectiveness of project management processes Ø Continuous improvement in project management practices
Jan 18, 2025
Full time
Role Profile: Technical PMO Manager Job Title: Technical PMO Manager Location: Warrington Reports To: Chief Digital and Information Officer (CDIO) Salary: £55,000 to £60,000 (plus car) Purpose of Role The Technical PMO Manager is responsible for the strategic oversight and management of the Project Management Office (PMO) with a focus on technical projects. This role ensures the successful delivery of key IT initiatives by implementing best practices, optimising resource allocation, and maintaining alignment with business objectives. Key Responsibilities Technical Portfolio Managemen t: Ø Develop and maintain the IT project portfolio, ensuring alignment with the organisation s strategic goals and technical requirements Ø Prioritise technical projects based on business value, resource availability, and risk assessment Ø Provide regular portfolio status updates to senior management and stakeholders Governance and Standards : Ø Establish and enforce project management standards, methodologies, and best practices (e.g., Agile, Waterfall, PRINCE2) tailored to technical projects Ø Develop and maintain PMO policies, procedures, and templates to ensure consistency and quality across technical projects Ø Conduct regular audits and reviews to ensure compliance with established standards Resource and Capacity Management : Ø Allocate technical resources effectively across projects, ensuring optimal utilisation and balancing workloads Ø Monitor resource capacity and demand, adjusting as necessary to meet project needs Ø Collaborate with HR and department heads to address resource gaps and develop talent pipelines Risk and Issue Management : Ø Identify, assess, and mitigate risks associated with technical projects, ensuring proactive issue resolution Ø Develop and maintain a risk management framework, including risk registers and mitigation plans Ø Facilitate risk workshops and training sessions for project teams Performance Monitoring and Reporting : Ø Track and report on project performance metrics, including scope, schedule, budget, and quality Ø Develop and maintain dashboards and reports to provide real-time visibility into project status Ø Conduct post-project reviews and lessons learned sessions to identify areas for improvement Stakeholder Engagement and Communication : Ø Collaborate with business leaders and project managers to ensure stakeholder needs are met and expectations are managed Ø Facilitate regular communication and reporting to stakeholders, including status updates, risk assessments, and performance metrics Ø Act as a liaison between the IT department and other business units, fostering a collaborative environment Continuous Improvement : Ø Drive improvements in project management processes, tools, and techniques to enhance efficiency and effectiveness Ø Stay current with industry trends and best practices, incorporating relevant innovations into the PMO Ø Lead initiatives to enhance project management maturity within the organisation Training and Development : Ø Provide training and support to project managers and teams, fostering a culture of excellence in project management Ø Develop and deliver training programs on project management methodologies, tools, and best practices Ø Mentor and coach project managers, helping them to develop their skills and advance their careers Skills and Qualifications Education : Bachelor s degree in information technology, Computer Science, Engineering, Business Administration, Project Management, or relevant experience Relevant certifications (e.g., PMP, PRINCE2, Agile) are highly desirable Experience : Extensive experience in project management, with a proven track record of managing complex technical IT projects and leading a PMO Demonstrated experience in portfolio management, governance, and resource management. Technical Expertise : Strong technical background with knowledge of IT infrastructure, software development, and systems integration Proficiency in project management software and tools (e.g., MS Project, JIRA, Trello) Leadership : Strong leadership and team management skills, with the ability to inspire and motivate project teams Experience in leading cross-functional teams and managing multiple projects simultaneously Communication : Excellent communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels Strong presentation and facilitation skills, with the ability to convey complex technical information clearly and concisely Analytical Skills : Strong analytical and problem-solving skills, with the ability to make data-driven decisions Ability to analyse technical requirements and translate them into actionable project plans. Organisational Skills : Exceptional organisational and multitasking abilities, with a keen attention to detail Ability to manage competing priorities and meet deadlines in a fast-paced environment. Adaptability : Ability to thrive in a dynamic environment and adapt to changing circumstances Resilient and able to maintain composure under pressure Personal Attributes : Proactive: Takes initiative and is able to anticipate and address project challenges Collaborative : Works effectively with diverse teams and stakeholders, fostering a collaborative environment Strategic Thinker : Able to see the big picture and align project outcomes with business goals Resilient : Maintains composure and effectiveness under pressure, adapting to changing circumstances Key Performance Indicators (KPIs) Ø Successful delivery of technical IT projects (on time, within budget, meeting requirements) Ø Alignment of project outcomes with business objectives Ø Stakeholder satisfaction and engagement levels Ø Efficiency and effectiveness of project management processes Ø Continuous improvement in project management practices
We are looking for an experienced and dynamic individual to join our team as Head of Facilities Management . This is an exciting opportunity to lead a professional FM service, ensuring high standards of service delivery and a safe, efficient working environment. Client Details Providing agriculture with cutting-edge science and innovation for the development of environmentally sustainable solutions for food and energy production . Description Key Responsibilities: Lead the Facilities Management (FM) service, ensuring compliance with statutory legislation and industry best practices. Ensure full adherence to health and safety regulations and conduct regular audits to maintain the highest standards. Manage and develop a multi-disciplinary FM team, ensuring clarity in roles, responsibilities, and performance expectations. Prepare and monitor budgets to ensure financial management is effective, ensuring that approved budgets are adhered to. Review and ensure accurate financial forecasts and management information reports are delivered on time. Motivate and lead your team, setting operational standards to deliver exceptional services. Develop business cases for capital investment, driving improvements in scientific and support services and sustainability goals. Manage technical specialists and ensure all processes are followed correctly. Oversee and ensure timely and accurate planning and delivery of Planned Preventative Maintenance (PPM) using CAFM systems. Lead sustainability initiatives, aiming to enhance environmental performance and meet sustainability targets. Manage third-party suppliers to ensure services are delivered to the agreed standards with effective performance reporting. Profile What We're Looking For: Qualification : HNC/HND or equivalent in Facilities Management or a relevant leadership qualification. Experience : A minimum of 10 years' experience in a similar role, demonstrating a proven track record in FM leadership and team management. Strong leadership skills, with the ability to motivate and inspire teams. Excellent financial acumen with the ability to manage budgets and ensure accurate forecasting. Expertise in health and safety compliance and FM service delivery. Job Offer Head of Facilities Management Salary: 52,000 per annum Pension: 7% contribution
Jan 18, 2025
Full time
We are looking for an experienced and dynamic individual to join our team as Head of Facilities Management . This is an exciting opportunity to lead a professional FM service, ensuring high standards of service delivery and a safe, efficient working environment. Client Details Providing agriculture with cutting-edge science and innovation for the development of environmentally sustainable solutions for food and energy production . Description Key Responsibilities: Lead the Facilities Management (FM) service, ensuring compliance with statutory legislation and industry best practices. Ensure full adherence to health and safety regulations and conduct regular audits to maintain the highest standards. Manage and develop a multi-disciplinary FM team, ensuring clarity in roles, responsibilities, and performance expectations. Prepare and monitor budgets to ensure financial management is effective, ensuring that approved budgets are adhered to. Review and ensure accurate financial forecasts and management information reports are delivered on time. Motivate and lead your team, setting operational standards to deliver exceptional services. Develop business cases for capital investment, driving improvements in scientific and support services and sustainability goals. Manage technical specialists and ensure all processes are followed correctly. Oversee and ensure timely and accurate planning and delivery of Planned Preventative Maintenance (PPM) using CAFM systems. Lead sustainability initiatives, aiming to enhance environmental performance and meet sustainability targets. Manage third-party suppliers to ensure services are delivered to the agreed standards with effective performance reporting. Profile What We're Looking For: Qualification : HNC/HND or equivalent in Facilities Management or a relevant leadership qualification. Experience : A minimum of 10 years' experience in a similar role, demonstrating a proven track record in FM leadership and team management. Strong leadership skills, with the ability to motivate and inspire teams. Excellent financial acumen with the ability to manage budgets and ensure accurate forecasting. Expertise in health and safety compliance and FM service delivery. Job Offer Head of Facilities Management Salary: 52,000 per annum Pension: 7% contribution
Job Title: Technical Lead Sofware Engineer 100,000 - 120,000 Location: Bristol, (Hybrid) Company Overview for Technical Lead Software Engineer My client is a leading Insurtech specialising in cyber reinsurance, providing advanced analytics and underwriting solutions that redefine how cyber risk is understood and managed. Their lean, skilled team thrives on collaboration, especially between their data science and engineering teams, to drive forward-thinking solutions and industry advancements. Job Description for Technical Lead Software Engineer You will be an experienced and hands-on Technical Lead Software Engineer to lead and grow the engineering team in Bristol. This is a strategic and technical leadership role that requires over 10 years of industry experience in building data-intensive applications within the financial sector, with a preference for experience in insurance. In this role, you will play a critical part in developing and scaling their cyber reinsurance platform while working closely with their data science and modelling teams. Key Responsibilities for Technical Lead Software Engineer Platform Development: Oversee the design, architecture, and development of our cyber reinsurance platform, incorporating features such as: o Reinsurance submission ingestion o Policy administration o Cyber risk modeling (attritional & catastrophe) o Portfolio optimization o Comprehensive reporting (exposure management, capital management, threat intelligence, large risk tracking, and clash analysis) Team Leadership: Manage and grow a full-stack engineering team with expertise in high-performance computing (HPC), large-scale data engineering, and web development. Cross-Functional Collaboration: Partner with data science and modeling teams to ensure seamless integration of analytical models into the platform. Strategic Scaling: Develop strategies to expand the platform across additional business lines. Hands-On Contribution: Actively engage with the codebase and tackle technical challenges, providing guidance and mentorship to the engineering team. Qualifications for Technical Lead Software Engineering Experience: o 10+ years in software engineering roles, focusing on data-intensive applications within the financial sector, including at least 5 years in leadership. o Preferable experience in the insurance industry. Technical Expertise: o Strong command of Python and PySpark. o Skilled in high-performance computing, large-scale data engineering, and full-stack web development. o Proficient in machine learning and analytics applications. o Experience with cloud infrastructure (GCP, AWS, Azure), DevOps tools (Docker, Terraform, Kubernetes), and data lakehouses (e.g., Databricks). o Familiarity with CI/CD pipelines and automated testing frameworks. Leadership Skills: o Proven track record in building, leading, and scaling high-performing engineering teams. o Demonstrated success in fostering collaboration between engineering and data science teams. Hands-On Aptitude: o Ability and enthusiasm for direct coding and problem-solving. o Knowledgeable about modern development practices and tools. Skills and Attributes for Head of Engineering Strategic Mindset: Aligns engineering initiatives with business goals. Excellent Communicator: Effectively conveys technical concepts to diverse stakeholders. Innovative: Enthusiastic about emerging technologies and industry trends. Analytical Problem Solver: Strong critical thinking skills to navigate complex technical issues. Collaborative Leader: Dedicated to creating an inclusive and cooperative team culture. How to apply for Technical Lead Software Engineering Please apply by following the links below.
Jan 18, 2025
Full time
Job Title: Technical Lead Sofware Engineer 100,000 - 120,000 Location: Bristol, (Hybrid) Company Overview for Technical Lead Software Engineer My client is a leading Insurtech specialising in cyber reinsurance, providing advanced analytics and underwriting solutions that redefine how cyber risk is understood and managed. Their lean, skilled team thrives on collaboration, especially between their data science and engineering teams, to drive forward-thinking solutions and industry advancements. Job Description for Technical Lead Software Engineer You will be an experienced and hands-on Technical Lead Software Engineer to lead and grow the engineering team in Bristol. This is a strategic and technical leadership role that requires over 10 years of industry experience in building data-intensive applications within the financial sector, with a preference for experience in insurance. In this role, you will play a critical part in developing and scaling their cyber reinsurance platform while working closely with their data science and modelling teams. Key Responsibilities for Technical Lead Software Engineer Platform Development: Oversee the design, architecture, and development of our cyber reinsurance platform, incorporating features such as: o Reinsurance submission ingestion o Policy administration o Cyber risk modeling (attritional & catastrophe) o Portfolio optimization o Comprehensive reporting (exposure management, capital management, threat intelligence, large risk tracking, and clash analysis) Team Leadership: Manage and grow a full-stack engineering team with expertise in high-performance computing (HPC), large-scale data engineering, and web development. Cross-Functional Collaboration: Partner with data science and modeling teams to ensure seamless integration of analytical models into the platform. Strategic Scaling: Develop strategies to expand the platform across additional business lines. Hands-On Contribution: Actively engage with the codebase and tackle technical challenges, providing guidance and mentorship to the engineering team. Qualifications for Technical Lead Software Engineering Experience: o 10+ years in software engineering roles, focusing on data-intensive applications within the financial sector, including at least 5 years in leadership. o Preferable experience in the insurance industry. Technical Expertise: o Strong command of Python and PySpark. o Skilled in high-performance computing, large-scale data engineering, and full-stack web development. o Proficient in machine learning and analytics applications. o Experience with cloud infrastructure (GCP, AWS, Azure), DevOps tools (Docker, Terraform, Kubernetes), and data lakehouses (e.g., Databricks). o Familiarity with CI/CD pipelines and automated testing frameworks. Leadership Skills: o Proven track record in building, leading, and scaling high-performing engineering teams. o Demonstrated success in fostering collaboration between engineering and data science teams. Hands-On Aptitude: o Ability and enthusiasm for direct coding and problem-solving. o Knowledgeable about modern development practices and tools. Skills and Attributes for Head of Engineering Strategic Mindset: Aligns engineering initiatives with business goals. Excellent Communicator: Effectively conveys technical concepts to diverse stakeholders. Innovative: Enthusiastic about emerging technologies and industry trends. Analytical Problem Solver: Strong critical thinking skills to navigate complex technical issues. Collaborative Leader: Dedicated to creating an inclusive and cooperative team culture. How to apply for Technical Lead Software Engineering Please apply by following the links below.
You will need to login before you can apply for a job. Site Name: Home Worker - USA, GSK House, Zug House Posted Date: Dec The Global Medical Director role is a unique opportunity for an experienced, innovative, and proactive medical professional to facilitate the understanding of the value of our medicines and vaccines, the science behind them and the public impact they can offer. This is accomplished by developing and implementing the global medical scientific strategic plan to generate insights, shape optimal care through scientific dialogue and education and delivering impact by generating and communicating the evidence and delivering solutions to close the gaps. Position can be Director or Sr. Director level- to be confirmed based on experience. The Global Medical Director for Blenrep will work in a thriving team of medical business leaders where people will be inspired to drive towards achieving our goals of getting Ahead of Disease Together and positively impacting patient and population health outcomes globally. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support the Global Medical Leads in the development and timely execution of practice changing Global Medical Affairs Plans (MAP) and Integrated Evidence plans (IEP) in partnership with key stakeholders through the GMAT and IET. Think globally, while deeply understanding priority LOC (Local Operating Company) needs and success measures. This is accomplished through extensive partnership and collaboration with LOC teams to understand landscape, market value drivers, unmet medical needs and timelines for deliverables required for their success. Partner across the internal ecosystem and with external partners to deliver Medical Plans that prioritize external impact above all else on time and on budget. Leverage insights and learnings, inputs into the design of clinical trials and development plans to optimize the positive impact for patients. Drive excellence in scientific engagement by developing a strong collaborative network of global external experts (HCPs, patients, payors and regulators) to be engaged in advice seeking activities and appropriate initiatives to advance clinical care and patient outcomes in partnership with the LOC Medical teams where those experts reside. Ensure colleagues have a robust knowledge of the relevant and emerging clinical evidence, supporting their training by partnering on the creation and delivery of high-quality scientific materials for both internal and external use. Partner with Global Product Strategy, Market Access, and core country teams to support/advise on core claims and material review. Ensure appropriate medical governance oversight including management of product-related issues with potential impact on patient safety and of risk assessment and mitigation plan associated with deliverables/strategies. Develop deep subject matter expertise on the product and therapy area as well as the ability to drive proactive strategic planning. Drive a culture and delivery mindset of future ready innovation which supports faster and specific solutions for patients. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD/MBBS/PharmD or PhD in clinical / scientific discipline related to hematology. 5 + years of experience in Medical Affairs including roles in LOCs and in global teams supporting pre/peri launch phases of assets. Writing, speaking, and creating highly technical medical content in English. Experience designing evidence and communication strategies at the global level. Experience developing global KOL relationships, implementing medical education initiatives, and implementing externally and internally sponsored research. Preferred Qualifications: If you have the following characteristics, it would be a plus: Previous clinical or scientific experience in hematology will be an added benefit. Robust understanding of internal and external codes of practice and regulations (certification where applicable). Demonstrated matrix leadership in previous roles with ability to build strong networks, manage complexity and cultural diversity. Experience in medical support for briefing documents for regulatory interactions and payor dossiers. General understanding of statistics, safety, regulatory requirements. Demonstrated experience with developing global or local medical strategies and asset launches, especially within a priority market. Skilled at simultaneous consideration of scientific data and practical healthcare delivery needs from diverse health systems to optimize medical implementation of innovation. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Jan 18, 2025
Full time
You will need to login before you can apply for a job. Site Name: Home Worker - USA, GSK House, Zug House Posted Date: Dec The Global Medical Director role is a unique opportunity for an experienced, innovative, and proactive medical professional to facilitate the understanding of the value of our medicines and vaccines, the science behind them and the public impact they can offer. This is accomplished by developing and implementing the global medical scientific strategic plan to generate insights, shape optimal care through scientific dialogue and education and delivering impact by generating and communicating the evidence and delivering solutions to close the gaps. Position can be Director or Sr. Director level- to be confirmed based on experience. The Global Medical Director for Blenrep will work in a thriving team of medical business leaders where people will be inspired to drive towards achieving our goals of getting Ahead of Disease Together and positively impacting patient and population health outcomes globally. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support the Global Medical Leads in the development and timely execution of practice changing Global Medical Affairs Plans (MAP) and Integrated Evidence plans (IEP) in partnership with key stakeholders through the GMAT and IET. Think globally, while deeply understanding priority LOC (Local Operating Company) needs and success measures. This is accomplished through extensive partnership and collaboration with LOC teams to understand landscape, market value drivers, unmet medical needs and timelines for deliverables required for their success. Partner across the internal ecosystem and with external partners to deliver Medical Plans that prioritize external impact above all else on time and on budget. Leverage insights and learnings, inputs into the design of clinical trials and development plans to optimize the positive impact for patients. Drive excellence in scientific engagement by developing a strong collaborative network of global external experts (HCPs, patients, payors and regulators) to be engaged in advice seeking activities and appropriate initiatives to advance clinical care and patient outcomes in partnership with the LOC Medical teams where those experts reside. Ensure colleagues have a robust knowledge of the relevant and emerging clinical evidence, supporting their training by partnering on the creation and delivery of high-quality scientific materials for both internal and external use. Partner with Global Product Strategy, Market Access, and core country teams to support/advise on core claims and material review. Ensure appropriate medical governance oversight including management of product-related issues with potential impact on patient safety and of risk assessment and mitigation plan associated with deliverables/strategies. Develop deep subject matter expertise on the product and therapy area as well as the ability to drive proactive strategic planning. Drive a culture and delivery mindset of future ready innovation which supports faster and specific solutions for patients. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD/MBBS/PharmD or PhD in clinical / scientific discipline related to hematology. 5 + years of experience in Medical Affairs including roles in LOCs and in global teams supporting pre/peri launch phases of assets. Writing, speaking, and creating highly technical medical content in English. Experience designing evidence and communication strategies at the global level. Experience developing global KOL relationships, implementing medical education initiatives, and implementing externally and internally sponsored research. Preferred Qualifications: If you have the following characteristics, it would be a plus: Previous clinical or scientific experience in hematology will be an added benefit. Robust understanding of internal and external codes of practice and regulations (certification where applicable). Demonstrated matrix leadership in previous roles with ability to build strong networks, manage complexity and cultural diversity. Experience in medical support for briefing documents for regulatory interactions and payor dossiers. General understanding of statistics, safety, regulatory requirements. Demonstrated experience with developing global or local medical strategies and asset launches, especially within a priority market. Skilled at simultaneous consideration of scientific data and practical healthcare delivery needs from diverse health systems to optimize medical implementation of innovation. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Sir Robert Pattinson Academy
Lincoln, Lincolnshire
Sir Robert Pattinson Academy Headmaster Mr D. J. Hardy BA (Hons) PGCE Teacher of Science - Physics Main Pay Range/Upper Pay Range Full Time Required: Easter 2025 or As soon as possible Sir Robert Pattinson Academy is an 11 - 18 comprehensive school where students are valued, happy, challenged and strive to achieve their best. The Academy provides rich learning experiences both in and outside of the classroom resulting in a great education. The Academy is situated on an extensive, beautiful site offering purpose-built facilities on the outskirts of Lincoln, towards the Nottinghamshire border. The area boasts affordable housing and good road and rail networks to the South and Midlands. Due to the significant growth of the Academy, we are currently recruiting for an enthusiastic and dynamic teacher to take on the position of Teacher of Science (Physics preferred), to join an OFSTED graded 'Good' Academy located in North Hykeham, Lincoln. This is a role which will allow the successful candidate to grow and develop within the Academy while taking on greater responsibility. You will be working closely within a team to promote a positive ethos in classrooms and across the faculty to ensure a stimulating learning environment. What we need We are seeking to recruit an exceptional full time Teacher of Science (Physics preferred) to join us in April 2025 or as soon as possible. The successful candidate will be looking for an opportunity to enhance their career in the classroom and have the ability to effectively develop their pedagogy and practice. Experience of teaching Physics across KS3-5 is desirable. In addition, you will need to be an enthusiastic, lively and versatile teacher with a passion for your subject and the desire to contribute to the development of the Science department and the Academy as a whole. The post would suit experienced teachers or ECTs, for whom an effective induction scheme is in place. This is an exciting time to join the Academy and support its improvement with an opportunity to make a difference within the subject area and across the Academy. What we can offer you: A beautiful cathedral city location Membership of the Teacher Pension Scheme Free on-site car parking and secure cycle store Cycle to work scheme. Education Mutual Health & Wellbeing services Occupational sick pay For further details and application forms please email via the button below. Please find our Child Protection Policy by clicking here Policies Sir Robert Pattinson Academy (srpa.co.uk) Closing date: Friday 24 January 2025 at 9am. Interview Date: W/c 27 January 2025. Sir Robert Pattinson Academy is proud to be a member of the 'Disability Confident Scheme'. We are committed to safeguarding and promoting the welfare of children and young people. We operate Enhanced DBS safeguarding procedures.
Jan 18, 2025
Full time
Sir Robert Pattinson Academy Headmaster Mr D. J. Hardy BA (Hons) PGCE Teacher of Science - Physics Main Pay Range/Upper Pay Range Full Time Required: Easter 2025 or As soon as possible Sir Robert Pattinson Academy is an 11 - 18 comprehensive school where students are valued, happy, challenged and strive to achieve their best. The Academy provides rich learning experiences both in and outside of the classroom resulting in a great education. The Academy is situated on an extensive, beautiful site offering purpose-built facilities on the outskirts of Lincoln, towards the Nottinghamshire border. The area boasts affordable housing and good road and rail networks to the South and Midlands. Due to the significant growth of the Academy, we are currently recruiting for an enthusiastic and dynamic teacher to take on the position of Teacher of Science (Physics preferred), to join an OFSTED graded 'Good' Academy located in North Hykeham, Lincoln. This is a role which will allow the successful candidate to grow and develop within the Academy while taking on greater responsibility. You will be working closely within a team to promote a positive ethos in classrooms and across the faculty to ensure a stimulating learning environment. What we need We are seeking to recruit an exceptional full time Teacher of Science (Physics preferred) to join us in April 2025 or as soon as possible. The successful candidate will be looking for an opportunity to enhance their career in the classroom and have the ability to effectively develop their pedagogy and practice. Experience of teaching Physics across KS3-5 is desirable. In addition, you will need to be an enthusiastic, lively and versatile teacher with a passion for your subject and the desire to contribute to the development of the Science department and the Academy as a whole. The post would suit experienced teachers or ECTs, for whom an effective induction scheme is in place. This is an exciting time to join the Academy and support its improvement with an opportunity to make a difference within the subject area and across the Academy. What we can offer you: A beautiful cathedral city location Membership of the Teacher Pension Scheme Free on-site car parking and secure cycle store Cycle to work scheme. Education Mutual Health & Wellbeing services Occupational sick pay For further details and application forms please email via the button below. Please find our Child Protection Policy by clicking here Policies Sir Robert Pattinson Academy (srpa.co.uk) Closing date: Friday 24 January 2025 at 9am. Interview Date: W/c 27 January 2025. Sir Robert Pattinson Academy is proud to be a member of the 'Disability Confident Scheme'. We are committed to safeguarding and promoting the welfare of children and young people. We operate Enhanced DBS safeguarding procedures.
As a Business Sales Lead with an expertise and depth of experience in the Learning and Capability Development space, you will play an important role in our businesses growth by creating sales strategies tailored to the learning sector. You will manage the development of the growth strategy for whitespace within our Learning and Capability service line Nazaré. You will work with the Heads of Department (HoDs), Client Engagement Teams (CET), and client influencers throughout Inizio. You will report into the Chief Growth Officer What you'll do Market analysis and strategy: You will develop plans specific to the market through conducting in-depth market research to identify trends and latest opportunities within the learning sector. You will develop and refine sale strategies and go-to-market plans to take advantage of insights and collaborate with relevant Nazaré and Client Engagement team members to ensure they understand their role in supporting this plan. Sales Growth: Increase revenue by identifying and targeting main accounts and high-potential clients. Identify and open up discussions with new buying points within our established main accounts by collaborating with Nazaré and CET Team members. Work across Inizio Engage and the broader Inizio portfolio to identify relevant targets and work with partners across the group to support pursuing leads. Ensure there is daily/weekly action against the growth canvass that delivers results in the form of lead generation, qualification, and conversion to sales. Innovation, differentiation, and presentation: Raise our profile in the market with main clients and prospective clients through marketing and main events - working with our sales enablement and marketing teams to ensure we have relevant assets and content to showcase our services. Remain up to date with industry trends and latest technologies within the learning space. Work as part of the central growth team, collaborating with the Learning CoE to recommend and implement strategies to differentiate our offering and remain ahead of competitors. What you'll need to have Experience and a demonstrable record of success in sales and business growth. Credible expertise within the training, learning, and capability development market. A creative mindset with the ability to inspire and develop positive working relationships both internally and externally. Experience establishing communication and engagement with prospects. A well-connected background/established network within the learning sector. A creative approach combined with the ability to take the lead on developing creds and presentations to resonate with target clients. Integrity in your approach to developing new business. Benefits Great compensation package. 25 days' annual leave plus public holidays, company closure over Christmas, plus a personal day. Volunteering leave. Private Medical Insurance. Life Insurance. Pension Scheme. Hybrid working. A bit about us . Engage XD is an unusually shaped communications group that creates experiences that inspire lasting change. We partner with clients to provide employee engagement, learning & training solutions, scientific engagement, and capability building, all underpinned by applied behavioural science. We engage internal and external audiences through the creation and delivery of live and virtual experiences, film, digital, and immersive content. Our family of brands is made up of: Emota, Forty1, and Nazarѐ.
Jan 18, 2025
Full time
As a Business Sales Lead with an expertise and depth of experience in the Learning and Capability Development space, you will play an important role in our businesses growth by creating sales strategies tailored to the learning sector. You will manage the development of the growth strategy for whitespace within our Learning and Capability service line Nazaré. You will work with the Heads of Department (HoDs), Client Engagement Teams (CET), and client influencers throughout Inizio. You will report into the Chief Growth Officer What you'll do Market analysis and strategy: You will develop plans specific to the market through conducting in-depth market research to identify trends and latest opportunities within the learning sector. You will develop and refine sale strategies and go-to-market plans to take advantage of insights and collaborate with relevant Nazaré and Client Engagement team members to ensure they understand their role in supporting this plan. Sales Growth: Increase revenue by identifying and targeting main accounts and high-potential clients. Identify and open up discussions with new buying points within our established main accounts by collaborating with Nazaré and CET Team members. Work across Inizio Engage and the broader Inizio portfolio to identify relevant targets and work with partners across the group to support pursuing leads. Ensure there is daily/weekly action against the growth canvass that delivers results in the form of lead generation, qualification, and conversion to sales. Innovation, differentiation, and presentation: Raise our profile in the market with main clients and prospective clients through marketing and main events - working with our sales enablement and marketing teams to ensure we have relevant assets and content to showcase our services. Remain up to date with industry trends and latest technologies within the learning space. Work as part of the central growth team, collaborating with the Learning CoE to recommend and implement strategies to differentiate our offering and remain ahead of competitors. What you'll need to have Experience and a demonstrable record of success in sales and business growth. Credible expertise within the training, learning, and capability development market. A creative mindset with the ability to inspire and develop positive working relationships both internally and externally. Experience establishing communication and engagement with prospects. A well-connected background/established network within the learning sector. A creative approach combined with the ability to take the lead on developing creds and presentations to resonate with target clients. Integrity in your approach to developing new business. Benefits Great compensation package. 25 days' annual leave plus public holidays, company closure over Christmas, plus a personal day. Volunteering leave. Private Medical Insurance. Life Insurance. Pension Scheme. Hybrid working. A bit about us . Engage XD is an unusually shaped communications group that creates experiences that inspire lasting change. We partner with clients to provide employee engagement, learning & training solutions, scientific engagement, and capability building, all underpinned by applied behavioural science. We engage internal and external audiences through the creation and delivery of live and virtual experiences, film, digital, and immersive content. Our family of brands is made up of: Emota, Forty1, and Nazarѐ.
Marketing Lead - IO Lung Location: London Salary: Competitive Salary & Benefits Advert Closing Date: 20th January 2025 Do you have expertise in, and a passion for, developing and leading brand strategies? Join us at AstraZeneca as we continue leadership in the area of IO Lung. As the Marketing Lead, you will be at the forefront of developing brand strategies for several indications, driving product adoption and delivering positive outcomes. You will collaborate with internal partners and key Lung customer groups, ensuring alignment with regional and global plans. This role offers an exciting opportunity to deliver agreed sales targets and customer value within defined resources. Accountabilities: Development of the brand strategy across our IO Lung portfolio and implementation of the tactical plan for new indication launches as well as managing established products. External strategy and commercial interaction with key customer groups within the particular therapeutic areas. Collaboration with key internal collaborators from Market Access, Medical, Sales, Diagnostics, and Senior Management. Delivery of sales and customer value within defined resources. Accountability for all marketing team results including tactical plan and support to local account-based working ensuring compliance with all AZ Governance Frameworks and the ABPI Code of Practice. Oversight of budget planning and management for the brand teams within the therapy area franchise. Development of forecasts for the brands in conjunction with the Franchise Heads and cross-functional team. Essential Skills/Experience: Degree qualified. Strong marketing leadership with a successful track record of growing market share and launching new products and brands. Creative marketing capabilities with thorough commercial business sense. Demonstrated experience in lung cancer, including knowledge of local and international thought leaders. Experience of working within cross-functional business units and managing multiple external and internal senior stakeholders. Proven success in Oncology Marketing leadership across several brands or therapy areas. In-depth understanding of Account Planning and Customer Engagement programmes and processes. In-depth understanding of local healthcare system pricing and reimbursement. Excellent communication and partnership leadership skills. Desirable Skills/Experience: MBA. Sales management experience. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. We work, on average, a minimum of three days per week from the office while respecting individual flexibility. Why AstraZeneca? At AstraZeneca's Oncology Business Unit, we are driven by our ambition to be world leaders in Oncology. We have a game-changing pipeline with countless new indications and targets. Since our renewed focus on building our Oncology function, we have had great success with 7 new Oncology medicines since 2013. We are ranked at the top of the invention scale with the "best pipeline" by 'IDEA Pharma'. We aim to deliver 6 new molecular entities by 2025, confident that we can change the practice of medicine and redefine cancer treatment. At AstraZeneca UK, we are committed to delivering against three missions: Accelerating the position of the UK as a global centre of excellence in life sciences. Redefining healthcare through fast and equitable access to the most effective medicines and high-quality care. Delivering sustainable leadership that prioritises healthy people, society, and planet. Our head office in Pancras Square offers us the strongest possible platform to transform the lives of patients, as the country's leading biopharmaceutical company. It brings AstraZeneca UK closer to our customers, partners, and collaborators in the UK's healthcare environment. Are you ready to join a team that's making a real impact on patients' lives? Apply now and let's reimagine medicine together! AZUK
Jan 18, 2025
Full time
Marketing Lead - IO Lung Location: London Salary: Competitive Salary & Benefits Advert Closing Date: 20th January 2025 Do you have expertise in, and a passion for, developing and leading brand strategies? Join us at AstraZeneca as we continue leadership in the area of IO Lung. As the Marketing Lead, you will be at the forefront of developing brand strategies for several indications, driving product adoption and delivering positive outcomes. You will collaborate with internal partners and key Lung customer groups, ensuring alignment with regional and global plans. This role offers an exciting opportunity to deliver agreed sales targets and customer value within defined resources. Accountabilities: Development of the brand strategy across our IO Lung portfolio and implementation of the tactical plan for new indication launches as well as managing established products. External strategy and commercial interaction with key customer groups within the particular therapeutic areas. Collaboration with key internal collaborators from Market Access, Medical, Sales, Diagnostics, and Senior Management. Delivery of sales and customer value within defined resources. Accountability for all marketing team results including tactical plan and support to local account-based working ensuring compliance with all AZ Governance Frameworks and the ABPI Code of Practice. Oversight of budget planning and management for the brand teams within the therapy area franchise. Development of forecasts for the brands in conjunction with the Franchise Heads and cross-functional team. Essential Skills/Experience: Degree qualified. Strong marketing leadership with a successful track record of growing market share and launching new products and brands. Creative marketing capabilities with thorough commercial business sense. Demonstrated experience in lung cancer, including knowledge of local and international thought leaders. Experience of working within cross-functional business units and managing multiple external and internal senior stakeholders. Proven success in Oncology Marketing leadership across several brands or therapy areas. In-depth understanding of Account Planning and Customer Engagement programmes and processes. In-depth understanding of local healthcare system pricing and reimbursement. Excellent communication and partnership leadership skills. Desirable Skills/Experience: MBA. Sales management experience. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. We work, on average, a minimum of three days per week from the office while respecting individual flexibility. Why AstraZeneca? At AstraZeneca's Oncology Business Unit, we are driven by our ambition to be world leaders in Oncology. We have a game-changing pipeline with countless new indications and targets. Since our renewed focus on building our Oncology function, we have had great success with 7 new Oncology medicines since 2013. We are ranked at the top of the invention scale with the "best pipeline" by 'IDEA Pharma'. We aim to deliver 6 new molecular entities by 2025, confident that we can change the practice of medicine and redefine cancer treatment. At AstraZeneca UK, we are committed to delivering against three missions: Accelerating the position of the UK as a global centre of excellence in life sciences. Redefining healthcare through fast and equitable access to the most effective medicines and high-quality care. Delivering sustainable leadership that prioritises healthy people, society, and planet. Our head office in Pancras Square offers us the strongest possible platform to transform the lives of patients, as the country's leading biopharmaceutical company. It brings AstraZeneca UK closer to our customers, partners, and collaborators in the UK's healthcare environment. Are you ready to join a team that's making a real impact on patients' lives? Apply now and let's reimagine medicine together! AZUK
I am on the hunt for an experienced and passionate Head of Technology to lead the UK technology operations for my client based in Birmingham. This role provides the chance to influence both local and global projects, reporting directly to the European Chief Technology Officer. You will blend technical expertise with strategic vision, managing a skilled team of engineers while driving the evolution of software solutions for complex market environments. This role requires someone from a hands on technical background that has moved into a senior leadership role and has experience of, architectural planning, and leadership. Key Responsibilities: Lead and manage the UK product development team to deliver innovative and high-quality software. Define and implement a strategic technology roadmap aligned with business goals. Apply hands-on coding skills while guiding the team to follow secure and efficient development practices. Collaborate with global teams to ensure architectural consistency and scalability. Oversee DevOps and infrastructure initiatives to deliver secure, cost-effective solutions. Build strong relationships with key stakeholders across various industries. Manage vendor relationships and maintain compliance Experience Required: A track record of success in leadership roles within technology-focused organizations. Excellent problem-solving, communication, and stakeholder management skills. Experience with complex markets or trading platforms is advantageous. Proven expertise in C# .NET and software development. Strong experience with cloud platforms such as AWS or Azure, including DevOps pipelines. A bachelor s or master s degree in Computer Science or a related field. This is your chance to take a pivotal role in shaping a cutting-edge technology function with a global reach. If you're a leader with a passion for innovation, I would love to hear from you!
Jan 18, 2025
Full time
I am on the hunt for an experienced and passionate Head of Technology to lead the UK technology operations for my client based in Birmingham. This role provides the chance to influence both local and global projects, reporting directly to the European Chief Technology Officer. You will blend technical expertise with strategic vision, managing a skilled team of engineers while driving the evolution of software solutions for complex market environments. This role requires someone from a hands on technical background that has moved into a senior leadership role and has experience of, architectural planning, and leadership. Key Responsibilities: Lead and manage the UK product development team to deliver innovative and high-quality software. Define and implement a strategic technology roadmap aligned with business goals. Apply hands-on coding skills while guiding the team to follow secure and efficient development practices. Collaborate with global teams to ensure architectural consistency and scalability. Oversee DevOps and infrastructure initiatives to deliver secure, cost-effective solutions. Build strong relationships with key stakeholders across various industries. Manage vendor relationships and maintain compliance Experience Required: A track record of success in leadership roles within technology-focused organizations. Excellent problem-solving, communication, and stakeholder management skills. Experience with complex markets or trading platforms is advantageous. Proven expertise in C# .NET and software development. Strong experience with cloud platforms such as AWS or Azure, including DevOps pipelines. A bachelor s or master s degree in Computer Science or a related field. This is your chance to take a pivotal role in shaping a cutting-edge technology function with a global reach. If you're a leader with a passion for innovation, I would love to hear from you!
Site Name: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage Posted Date: Dec 3 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data. You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies. In this role you will Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans. Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets. Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data. Lead interactions with local/regional regulatory authorities. Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects. Ensure compliance with global/regional requirements at all stages of the product life cycle. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in biological or healthcare science. Experience in the drug development process within regulatory affairs. Proven ability to manage development, submission, and approval activities in different regions globally. Ability to develop necessary specialist knowledge for the product in a specific oncology disease area. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced Scientific Degree (PhD, MD, PharmD). Knowledge of all phases of the drug development process in regulatory affairs. Capability to lead regional development, submission, and approval activities in local region(s). Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine. Creative regulatory problem-solving capabilities, balancing agency expectations and compliance. Closing Date for Applications - 31 Jan 2025 (COB) At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Jan 18, 2025
Full time
Site Name: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage Posted Date: Dec 3 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data. You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies. In this role you will Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans. Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets. Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data. Lead interactions with local/regional regulatory authorities. Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects. Ensure compliance with global/regional requirements at all stages of the product life cycle. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in biological or healthcare science. Experience in the drug development process within regulatory affairs. Proven ability to manage development, submission, and approval activities in different regions globally. Ability to develop necessary specialist knowledge for the product in a specific oncology disease area. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced Scientific Degree (PhD, MD, PharmD). Knowledge of all phases of the drug development process in regulatory affairs. Capability to lead regional development, submission, and approval activities in local region(s). Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine. Creative regulatory problem-solving capabilities, balancing agency expectations and compliance. Closing Date for Applications - 31 Jan 2025 (COB) At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Our Team The Data team is a cross-functional team of experienced and passionate data enthusiasts. We use and own modern data tools (Fivetran, Snowflake, dbt, Looker) and cover a diverse range of data problems and stakeholders. What we're offering you: Flexible hours and summer hours Competitive holiday benefits (25 days a year paid holiday, plus 8 bank holidays) Work from anywhere for 2 weeks a year Life Assurance to protect your loved ones Benefits allowance for health, dental, and vision coverage Defined Contribution Pension and Salary Sacrifice Scheme Be Well: Our award-winning wellbeing and mental health programme to support all MVFers and their families Family Forward support for our MVF parents and their mini-mes Free breakfast when in the office The Role MVF is seeking an exceptionally skilled and driven Data Scientist to deliver upon our plans for growth. This is a hybrid-role across Data Science and ML Engineering: we would like someone with either a background in machine learning engineering, but a desire to learn and grow in creating data science products or vice versa. You will be pivotal in building our Data Science and Machine Learning capabilities in order to hit our strategic goals. These are the problem spaces in our backlog: Recommendation systems - predicting cross-sell opportunities Imbalanced classification - predicting the value of leads Optimisation (e.g., Linear programming) - optimising which leads / products we sell to which client Forecasting - predicting client demand Experimentation You will be communicative, commercially-minded, with a strong team-spirit. You will enjoy collaborating with stakeholders, as you will be delivering value across the business, from Paid Marketing to Operations and Sales. Reporting to the Head of Data, you will collaborate closely with a Senior Data Scientist to deliver upon our roadmap. You will have support from Analytics Engineering teams to build and maintain pipelines and from Software Engineering teams to productionize models. The ideal candidate will relish the opportunity to understand their stakeholders more deeply and define where they think they (and Data Science) can add the most value. With support, they will be excited to build data science models from inception to production. Responsibilities: Build and manage a Machine Learning Platform by selecting and integrating tools that complement the existing data ecosystem (AWS, Snowflake) Productionise ML models, ensuring that they are running scalably, efficiently and robustly Develop Data Science/Machine Learning products addressing key business needs in accordance with ML best practices What Success Looks Like: Building effective and efficient Data Science models that deliver measurable business value Ensuring Machine Learning is executed using best-in-class tools, techniques, and approaches within budget and time constraints Ensuring exceptional data integrity and quality across all projects Develop ML monitoring and observability pipeline for deployed models Our Ideal MVF'er: 3+ years of experience in a dedicated Data Science/Machine Learning role; additional data or commercial experience is a plus Strong understanding of mathematical background, focusing on statistics and linear algebra Highly proficient in Python (Pandas, Scikit-Learn, PyTorch, PySpark) and SQL Experience with Snowflake (function & procedure) and Snowpark is a plus Experience with unit and integration tests Strong understanding of machine learning algorithms and best practices Vision for MLOps best practices, particularly regarding version control, Docker, MLFlow, CI/CD Strong communication skills, with the ability to engage effectively with diverse stakeholders Good commercial understanding; knowledge of marketing operations is a bonus
Jan 18, 2025
Full time
Our Team The Data team is a cross-functional team of experienced and passionate data enthusiasts. We use and own modern data tools (Fivetran, Snowflake, dbt, Looker) and cover a diverse range of data problems and stakeholders. What we're offering you: Flexible hours and summer hours Competitive holiday benefits (25 days a year paid holiday, plus 8 bank holidays) Work from anywhere for 2 weeks a year Life Assurance to protect your loved ones Benefits allowance for health, dental, and vision coverage Defined Contribution Pension and Salary Sacrifice Scheme Be Well: Our award-winning wellbeing and mental health programme to support all MVFers and their families Family Forward support for our MVF parents and their mini-mes Free breakfast when in the office The Role MVF is seeking an exceptionally skilled and driven Data Scientist to deliver upon our plans for growth. This is a hybrid-role across Data Science and ML Engineering: we would like someone with either a background in machine learning engineering, but a desire to learn and grow in creating data science products or vice versa. You will be pivotal in building our Data Science and Machine Learning capabilities in order to hit our strategic goals. These are the problem spaces in our backlog: Recommendation systems - predicting cross-sell opportunities Imbalanced classification - predicting the value of leads Optimisation (e.g., Linear programming) - optimising which leads / products we sell to which client Forecasting - predicting client demand Experimentation You will be communicative, commercially-minded, with a strong team-spirit. You will enjoy collaborating with stakeholders, as you will be delivering value across the business, from Paid Marketing to Operations and Sales. Reporting to the Head of Data, you will collaborate closely with a Senior Data Scientist to deliver upon our roadmap. You will have support from Analytics Engineering teams to build and maintain pipelines and from Software Engineering teams to productionize models. The ideal candidate will relish the opportunity to understand their stakeholders more deeply and define where they think they (and Data Science) can add the most value. With support, they will be excited to build data science models from inception to production. Responsibilities: Build and manage a Machine Learning Platform by selecting and integrating tools that complement the existing data ecosystem (AWS, Snowflake) Productionise ML models, ensuring that they are running scalably, efficiently and robustly Develop Data Science/Machine Learning products addressing key business needs in accordance with ML best practices What Success Looks Like: Building effective and efficient Data Science models that deliver measurable business value Ensuring Machine Learning is executed using best-in-class tools, techniques, and approaches within budget and time constraints Ensuring exceptional data integrity and quality across all projects Develop ML monitoring and observability pipeline for deployed models Our Ideal MVF'er: 3+ years of experience in a dedicated Data Science/Machine Learning role; additional data or commercial experience is a plus Strong understanding of mathematical background, focusing on statistics and linear algebra Highly proficient in Python (Pandas, Scikit-Learn, PyTorch, PySpark) and SQL Experience with Snowflake (function & procedure) and Snowpark is a plus Experience with unit and integration tests Strong understanding of machine learning algorithms and best practices Vision for MLOps best practices, particularly regarding version control, Docker, MLFlow, CI/CD Strong communication skills, with the ability to engage effectively with diverse stakeholders Good commercial understanding; knowledge of marketing operations is a bonus
About Us Are you ready to change the world? Harris Science Academy East London is a new, small school with big ambitions. We are in the top 3% of schools nationally for year on year improvement and in the top 20 most improved schools in London. Join us on our mission to help our children become leaders in their chosen field with many leading in science and to become one of the top schools in the UK. This is no ordinary school. Situated in an eclectic array of buildings next to the renowned Three Mills Studios (location of BBC's Masterchef) amongst the iconic East London canal network, this is a unique setting to provide a life changing education for the children of East London. We believe we will succeed in this mission through a relentless focus on the basic functions of a high performing school: Unified leadership and alignment behind a powerful mission. Exemplary student behaviour. A well-taught, unapologetically academic education for all children. Regular opportunities for character development. Every member of our school community is a leader. We believe that leadership does not have to be macho or at the expense of others. Our values of GRACE help us to achieve success in a collegiate and sustainable way: Growth - the belief that we can always improve and that feedback from others is essential for our development. Responsibility - we own our decisions and recognise when we need to put things right or make a change. Ambition - the belief that access to the top grades, the best universities and elite careers are available for our children. Compassion - we are kind to others and grateful for what we have. Excellence - we prioritise doing the basics well day after day, so we build habits that lead to success. The school joined the Harris Federation in September 2022. The Harris Federation is the most successful large multi-academy trust in the UK and the only large trust where disadvantaged students secured a positive progress score in 2022. We are hugely proud of the work we do to support the most vulnerable children in the UK. The Federation has made a significant financial investment in the Academy, with upgrades to Sixth Form provision, buildings and IT. The Federation subject consultants provide industry leading support to middle leaders to deliver the best education possible for all children across the Federation. If you are aligned, driven and committed to doing what works, this is an excellent opportunity to join an organisation undergoing rapid transformation. Main Areas of Responsibility The purpose of your role will be: To be accountable for leading, managing and developing the subject area. To raise standards of student attainment and achievement within the whole subject/curriculum area and to monitor and support student progress. To ensure the provision of an appropriately broad, balanced, relevant and differentiated curriculum for students studying in the department, in accordance with the aims of the academy and the curricular policies determined by the Governing Body and Principal. To teach the relevant subject across the age and ability range. To facilitate and encourage a learning experience which provides students with the opportunity to achieve their individual potential. To effectively manage and deploy staff, financial and physical resources within the department. To share and support the school's responsibility to provide and monitor opportunities for personal and academic growth. Your main areas of responsibility will fall under the areas of: Operational and strategic planning (including formulating the subject and faculty improvement plans, and leading the development of appropriate syllabuses, resources, schemes of work, marking policies, assessment and teaching strategies) Ensuring the delivery of an appropriate, comprehensive, high quality and cost effective curriculum and leading development of the subject and its delivery Staff development (including recruiting, building and managing an effective team of motivated staff) Student outcomes (including ensuring the effective operation of target setting, monitoring and evaluation systems and the input and maintenance of accurate student data) Pastoral system (including being a form tutor to a selected group of students) Teaching, including acting as an outstanding role model Qualifications & Experience We would like to hear from you if you: Hold QTS (or equivalent) and a relevant undergraduate degree, and, ideally, management training Demonstrate successful teaching of GCSE at good or better level Have experience of initiation and effective management of change Show evidence of raising achievement in present post and showing good value added for groups Have knowledge of current curriculum developments in subject and their implications Have good knowledge and understanding of current educational thinking Show good understanding of how children learn and how to raise standards of achievement Have good communication skills in speech and writing Display excellent organisational skills Are able to build and sustain professional standards and relationships with students Are able to contribute towards creating a safe and protective environment For a full job description and person specification, please download the Job Pack. Professional Development & Benefits Our people are at the heart of our success. We have developed a strong culture of collaboration and best practice, with professional development and career planning at its centre. We invest in our staff with support, coaching, mentoring, and a wide range of top-quality training programmes delivered at every level. In addition to the opportunities for career development and progression, we also offer a competitive rewards and benefits package which includes our Harris Allowance for teachers on MPS/UPS, a Performance and Loyalty Bonus, Pension Scheme with generous employer contributions, a Wellbeing Cash Plan and many other benefits. Learn more about our benefits on our website.
Jan 18, 2025
Full time
About Us Are you ready to change the world? Harris Science Academy East London is a new, small school with big ambitions. We are in the top 3% of schools nationally for year on year improvement and in the top 20 most improved schools in London. Join us on our mission to help our children become leaders in their chosen field with many leading in science and to become one of the top schools in the UK. This is no ordinary school. Situated in an eclectic array of buildings next to the renowned Three Mills Studios (location of BBC's Masterchef) amongst the iconic East London canal network, this is a unique setting to provide a life changing education for the children of East London. We believe we will succeed in this mission through a relentless focus on the basic functions of a high performing school: Unified leadership and alignment behind a powerful mission. Exemplary student behaviour. A well-taught, unapologetically academic education for all children. Regular opportunities for character development. Every member of our school community is a leader. We believe that leadership does not have to be macho or at the expense of others. Our values of GRACE help us to achieve success in a collegiate and sustainable way: Growth - the belief that we can always improve and that feedback from others is essential for our development. Responsibility - we own our decisions and recognise when we need to put things right or make a change. Ambition - the belief that access to the top grades, the best universities and elite careers are available for our children. Compassion - we are kind to others and grateful for what we have. Excellence - we prioritise doing the basics well day after day, so we build habits that lead to success. The school joined the Harris Federation in September 2022. The Harris Federation is the most successful large multi-academy trust in the UK and the only large trust where disadvantaged students secured a positive progress score in 2022. We are hugely proud of the work we do to support the most vulnerable children in the UK. The Federation has made a significant financial investment in the Academy, with upgrades to Sixth Form provision, buildings and IT. The Federation subject consultants provide industry leading support to middle leaders to deliver the best education possible for all children across the Federation. If you are aligned, driven and committed to doing what works, this is an excellent opportunity to join an organisation undergoing rapid transformation. Main Areas of Responsibility The purpose of your role will be: To be accountable for leading, managing and developing the subject area. To raise standards of student attainment and achievement within the whole subject/curriculum area and to monitor and support student progress. To ensure the provision of an appropriately broad, balanced, relevant and differentiated curriculum for students studying in the department, in accordance with the aims of the academy and the curricular policies determined by the Governing Body and Principal. To teach the relevant subject across the age and ability range. To facilitate and encourage a learning experience which provides students with the opportunity to achieve their individual potential. To effectively manage and deploy staff, financial and physical resources within the department. To share and support the school's responsibility to provide and monitor opportunities for personal and academic growth. Your main areas of responsibility will fall under the areas of: Operational and strategic planning (including formulating the subject and faculty improvement plans, and leading the development of appropriate syllabuses, resources, schemes of work, marking policies, assessment and teaching strategies) Ensuring the delivery of an appropriate, comprehensive, high quality and cost effective curriculum and leading development of the subject and its delivery Staff development (including recruiting, building and managing an effective team of motivated staff) Student outcomes (including ensuring the effective operation of target setting, monitoring and evaluation systems and the input and maintenance of accurate student data) Pastoral system (including being a form tutor to a selected group of students) Teaching, including acting as an outstanding role model Qualifications & Experience We would like to hear from you if you: Hold QTS (or equivalent) and a relevant undergraduate degree, and, ideally, management training Demonstrate successful teaching of GCSE at good or better level Have experience of initiation and effective management of change Show evidence of raising achievement in present post and showing good value added for groups Have knowledge of current curriculum developments in subject and their implications Have good knowledge and understanding of current educational thinking Show good understanding of how children learn and how to raise standards of achievement Have good communication skills in speech and writing Display excellent organisational skills Are able to build and sustain professional standards and relationships with students Are able to contribute towards creating a safe and protective environment For a full job description and person specification, please download the Job Pack. Professional Development & Benefits Our people are at the heart of our success. We have developed a strong culture of collaboration and best practice, with professional development and career planning at its centre. We invest in our staff with support, coaching, mentoring, and a wide range of top-quality training programmes delivered at every level. In addition to the opportunities for career development and progression, we also offer a competitive rewards and benefits package which includes our Harris Allowance for teachers on MPS/UPS, a Performance and Loyalty Bonus, Pension Scheme with generous employer contributions, a Wellbeing Cash Plan and many other benefits. Learn more about our benefits on our website.
You will need to login before you can apply for a job. Safety, Evaluation & Risk Management (SERM) Associate Medical Director Site Name: Belgium-Wavre, UK - London - New Oxford Street Posted Date: Dec Job purpose: Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Your responsibilities: Responsible for signal detection and evaluation activities for assigned products. Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician). Author the SERM safety contribution to global regulatory submissions in partnership with the product physician. May respond to auditors/inspectors' requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines. Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation. Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems. Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality. Cross-functional Matrix team leadership: Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling. Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency. May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. Build strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others. Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Present complex issues to senior staff members at the GSK Senior Governance Committees. Demonstrate initiative and creativity in performing tasks and responsibilities. Proactively contribute ideas to improve existing operations. Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation. Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listen and respond appropriately to the views and feedback of others. Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role. Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective. Why you? We are looking for professionals with these required skills to achieve our goals: Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications. Substantial experience in pharmacovigilance or drug development. Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities. Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Experience working in large matrix organizations. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Jan 18, 2025
Full time
You will need to login before you can apply for a job. Safety, Evaluation & Risk Management (SERM) Associate Medical Director Site Name: Belgium-Wavre, UK - London - New Oxford Street Posted Date: Dec Job purpose: Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Your responsibilities: Responsible for signal detection and evaluation activities for assigned products. Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician). Author the SERM safety contribution to global regulatory submissions in partnership with the product physician. May respond to auditors/inspectors' requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines. Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation. Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems. Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality. Cross-functional Matrix team leadership: Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling. Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency. May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently. Build strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others. Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Present complex issues to senior staff members at the GSK Senior Governance Committees. Demonstrate initiative and creativity in performing tasks and responsibilities. Proactively contribute ideas to improve existing operations. Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation. Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listen and respond appropriately to the views and feedback of others. Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role. Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective. Why you? We are looking for professionals with these required skills to achieve our goals: Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications. Substantial experience in pharmacovigilance or drug development. Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities. Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. Experience working in large matrix organizations. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Head of Product Engineering (Quality), Amazon Private Brand Job ID: Beijing Century Joyo Information Technology Co., Ltd. Shenzhen Branch The Amazon Private Label Quality Team is looking for a smart, energetic, hard-working, and creative team player to join our team. This is an exciting and challenging position where you will be responsible for supporting Amazon's Private Brands global products development and validation. In this role as Head of Product Engineering (Quality), you will lead and manage a team of quality development managers across multiple product categories and marketplaces. Additionally, you will support and drive process improvement initiatives across Amazon. Responsibilities: Demonstrate ability to manage multiple complex projects - work prioritization, planning, and task delegation. Manage quality metrics and performance by ensuring necessary reviews and actions are in place, leading meetings and projects as needed globally. This involves determining and executing strategies and goals for improving quality and productivity. Improve visibility of product development and validation processes by designing appropriate reporting and communicating plans to partners and stakeholders. Own & drive the product development roadmap for management metrics and provide key interface and insightful analysis regarding headcount and capital resources. Integrate strong and clear analysis and business rationale into sound decision-making. BASIC QUALIFICATIONS - Bachelor's degree in science or engineering. - Strong knowledge of product development and product quality processes in diverse industries. - 10 years of experience in product development, manufacturing, or testing in the manufacturing sector or sourcing office of a global retailer. - Process and data-oriented. - Excellent written and verbal communication skills. - Strong attention to detail and organizational skills. - Ability to work with technical and non-technical business owners to get things done. - Must be able to think creatively and possess strong analytical and problem-solving skills. PREFERRED QUALIFICATIONS - Master's degree in Business, Engineering, or a Scientific discipline preferred. - 10+ years of experience successfully managing complex product programs, with large, technically-savvy, cross-functional teams. Consumer electronics experience is a plus. - Experience with multiple concurrent projects with aggressive schedules. - Familiarity with Agile development methodology. - Product life-cycle end-to-end management experience. Posted: October 25, 2024 (Updated 8 days ago) Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
Jan 18, 2025
Full time
Head of Product Engineering (Quality), Amazon Private Brand Job ID: Beijing Century Joyo Information Technology Co., Ltd. Shenzhen Branch The Amazon Private Label Quality Team is looking for a smart, energetic, hard-working, and creative team player to join our team. This is an exciting and challenging position where you will be responsible for supporting Amazon's Private Brands global products development and validation. In this role as Head of Product Engineering (Quality), you will lead and manage a team of quality development managers across multiple product categories and marketplaces. Additionally, you will support and drive process improvement initiatives across Amazon. Responsibilities: Demonstrate ability to manage multiple complex projects - work prioritization, planning, and task delegation. Manage quality metrics and performance by ensuring necessary reviews and actions are in place, leading meetings and projects as needed globally. This involves determining and executing strategies and goals for improving quality and productivity. Improve visibility of product development and validation processes by designing appropriate reporting and communicating plans to partners and stakeholders. Own & drive the product development roadmap for management metrics and provide key interface and insightful analysis regarding headcount and capital resources. Integrate strong and clear analysis and business rationale into sound decision-making. BASIC QUALIFICATIONS - Bachelor's degree in science or engineering. - Strong knowledge of product development and product quality processes in diverse industries. - 10 years of experience in product development, manufacturing, or testing in the manufacturing sector or sourcing office of a global retailer. - Process and data-oriented. - Excellent written and verbal communication skills. - Strong attention to detail and organizational skills. - Ability to work with technical and non-technical business owners to get things done. - Must be able to think creatively and possess strong analytical and problem-solving skills. PREFERRED QUALIFICATIONS - Master's degree in Business, Engineering, or a Scientific discipline preferred. - 10+ years of experience successfully managing complex product programs, with large, technically-savvy, cross-functional teams. Consumer electronics experience is a plus. - Experience with multiple concurrent projects with aggressive schedules. - Familiarity with Agile development methodology. - Product life-cycle end-to-end management experience. Posted: October 25, 2024 (Updated 8 days ago) Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
Executive Director and Head Established Products Therapeutic Group Sector: Science and Pharmaceutical, Technology Role: Executive Contract Type: Permanent Hours: Full Time Site Name: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, GSK HQ, USA - Massachusetts - Waltham, Zug House Posted Date: Dec Job Purpose The Executive Director is accountable to the SVP, Regulatory Affairs Therapeutic Group, for influencing and driving the overall direction and strategy for the Established Products (EP) Therapeutic Group via the development and implementation of innovative regulatory strategies to optimize the life cycle management including divestment opportunities. The role will require extensive matrix working within GSK to SVP level and representing GSK with regulatory agencies as appropriate. This role will oversee the budget, staffing and operations. The Executive Director has full accountability for overseeing regulatory support for the EP portfolio, including the associated communication strategy to all regulatory authorities. The Executive Director is directly accountable for regulatory filings (excluding CMC and labelling), interactions globally and works with those outside of GRA (e.g. LOC, commercial and manufacturing) to facilitate other international filings. The Executive Director ensures that sound regulatory practices are fully integrated into regulatory work, that all regulatory obligations are met and that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically and technically accurate, of high quality, regulatory compliant and presented in a manner that facilitates agency review. The incumbent works across the GRA matrix with the relevant functional areas to ensure connectivity and alignment of activities for labelling and CMC. Key Responsibilities Leads directly and indirectly all regulatory activity in support of assigned EP product portfolio, working across the regulatory matrix to ensure alignment with business strategies. Contributes to the creation and implementation of product life cycle plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications. Represents the global regulatory function as the business partner to the General Medicine commercial leadership team and General Medicine PALT ensuring regulatory insights are incorporated into business strategies, regulatory risks are managed and obligations met. Provides leadership to Portfolio Optimisation regulatory activities including market expansion and divestment/discontinuation in support of business goals including representation on senior boards including Portfolio Optimisation Board. Provides leadership of function assessing and responding to changing business unit strategy; define and build regulatory capabilities to support. Exhibits leadership in the formulation and execution of global regulatory strategies and assist in the development of and implementation of policies and strategies that optimize product stewardship. Monitors and anticipates regulatory, scientific and pertinent legal issues related to the regional portfolio and assess potential impact on the Company, to advise management on events of significance to the Company's business interests; influences changes in guidelines and regulations to strengthen the regulatory review process and ensures core operations are proactively aligned with emerging policies. Acts as a credible, influential, respected spokesperson with external agencies and third parties, ensuring appropriate, proactive communication and assuring collaborative approaches to agency and third party interactions. Works with other stakeholders to proactively shape the external environment in a manner consistent with GSK principles and priorities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree 10+ years' experience in Regulatory Affairs Previous management line-management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial, licensing, supply chain and life cycle management requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities globally Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Jan 18, 2025
Full time
Executive Director and Head Established Products Therapeutic Group Sector: Science and Pharmaceutical, Technology Role: Executive Contract Type: Permanent Hours: Full Time Site Name: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, GSK HQ, USA - Massachusetts - Waltham, Zug House Posted Date: Dec Job Purpose The Executive Director is accountable to the SVP, Regulatory Affairs Therapeutic Group, for influencing and driving the overall direction and strategy for the Established Products (EP) Therapeutic Group via the development and implementation of innovative regulatory strategies to optimize the life cycle management including divestment opportunities. The role will require extensive matrix working within GSK to SVP level and representing GSK with regulatory agencies as appropriate. This role will oversee the budget, staffing and operations. The Executive Director has full accountability for overseeing regulatory support for the EP portfolio, including the associated communication strategy to all regulatory authorities. The Executive Director is directly accountable for regulatory filings (excluding CMC and labelling), interactions globally and works with those outside of GRA (e.g. LOC, commercial and manufacturing) to facilitate other international filings. The Executive Director ensures that sound regulatory practices are fully integrated into regulatory work, that all regulatory obligations are met and that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically and technically accurate, of high quality, regulatory compliant and presented in a manner that facilitates agency review. The incumbent works across the GRA matrix with the relevant functional areas to ensure connectivity and alignment of activities for labelling and CMC. Key Responsibilities Leads directly and indirectly all regulatory activity in support of assigned EP product portfolio, working across the regulatory matrix to ensure alignment with business strategies. Contributes to the creation and implementation of product life cycle plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications. Represents the global regulatory function as the business partner to the General Medicine commercial leadership team and General Medicine PALT ensuring regulatory insights are incorporated into business strategies, regulatory risks are managed and obligations met. Provides leadership to Portfolio Optimisation regulatory activities including market expansion and divestment/discontinuation in support of business goals including representation on senior boards including Portfolio Optimisation Board. Provides leadership of function assessing and responding to changing business unit strategy; define and build regulatory capabilities to support. Exhibits leadership in the formulation and execution of global regulatory strategies and assist in the development of and implementation of policies and strategies that optimize product stewardship. Monitors and anticipates regulatory, scientific and pertinent legal issues related to the regional portfolio and assess potential impact on the Company, to advise management on events of significance to the Company's business interests; influences changes in guidelines and regulations to strengthen the regulatory review process and ensures core operations are proactively aligned with emerging policies. Acts as a credible, influential, respected spokesperson with external agencies and third parties, ensuring appropriate, proactive communication and assuring collaborative approaches to agency and third party interactions. Works with other stakeholders to proactively shape the external environment in a manner consistent with GSK principles and priorities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree 10+ years' experience in Regulatory Affairs Previous management line-management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial, licensing, supply chain and life cycle management requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities globally Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
You will need to login before you can apply for a job. Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Self-motivated and independent worker. Compensation and Benefits: The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Jan 18, 2025
Full time
You will need to login before you can apply for a job. Site Name: Home Worker - USA, Home Worker - GBR Posted Date: Dec Details: We need exceptionally talented and committed Statisticians to apply quantitative skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer. You will provide global statistical support in non-registrational data generation, secondary publications and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients. You will also collaborate with R&D, medical and commercial organizations as well as global RWE and Health Outcomes teams to deliver a diverse stream of work to support evidence generation for market access of GSK marketed oncology products and late stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our Statisticians have opportunities to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support. Why you? Basic Qualifications: MSc with 5+ years or PhD with 2+ years in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Excellent interpersonal and communication skills, including: Experience with building and maintaining strong working relationships. Explaining novel and standard methods to scientific and clinical senior stakeholders. Experience successfully influencing effectively across functions and levels of an organization. Preferred Qualifications: Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products. Oncology experience. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. Capable of applying innovative statistical thinking. Experience with SAS or R preferred. Self-motivated and independent worker. Compensation and Benefits: The annual base salary for new hires in this position ranges from $115,600 to $156,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Senior Director Quality Business Partner: Clinical Development Sector: Audit Role: Senior Executive Contract Type: Permanent Hours: Full Time Site Name: UK - London - New Oxford Street, UK - Hertfordshire - Stevenage Posted Date: Nov Do you have a passion for developing and delivering a quality strategy for clinical development? If so, the Senior Director Quality Business Partner: Clinical Development role could be an exciting opportunity to explore. The Senior Director Quality Business Partner: Clinical Development is responsible for developing and delivering the quality strategy for the portfolio within the scope of Clinical Development. The position will develop methods to effectively and efficiently provide proactive quality support and consultation and drive quality into the business. The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK development processes are effective in ensuring the integrity of the data, compliance with external regulatory requirements and internal GSK requirements, and protection of patients. The Senior Director, QBP Clinical Development is a member of the Functional Process Quality Leadership team and, with other members of the LT, is responsible for the strategy and direction of this function. Responsibilities include: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include: Has direct accountability for the quality strategy for Asia Development, Clinical Operations and the Addenbrookes Clinical Pharmacology Unit (CUC). Build and lead a Quality team that provides experienced quality support for Asia Development, Clinical Operations and process-related projects and initiatives. Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs of the organization, regulatory requirements and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provide guidance and expectations to the business to build in quality by design and to enable the execution of external regulations and internal standards. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partners and executive management. Risk Assessment and Audit Strategy Oversee risk assessments for the audit universe within the area of responsibility, ensuring that high-risk areas are identified and prioritized for audits or other quality interventions. Provide input into the global audit plan based on identified signals/trends/risks/gaps. Inspection Readiness Foster a culture of inspection readiness by developing proactive quality strategies, leading inspection readiness initiatives, and supporting successful regulatory inspections. Leadership/People Management Build and maintain a Clinical Development Quality team by creating an environment that attracts, develops and retains high-quality employees. Knowledge Sharing and Quality Culture Promote a strong quality culture across the Development organization, emphasizing the importance of quality in achieving quality and business objectives. Champion the continuous improvement of quality systems and processes, fostering a culture of accountability, innovation and excellence. Cross-functional collaboration Collaborate closely with Clinical Operations, Asia Development, OCMO and other functions to ensure quality is integrated into clinical development strategies and operations. Serve as a trusted partner to senior leadership, providing expert guidance on quality risks, challenges, and opportunities related to clinical development. Other Lead multidisciplinary or cross-functional work/project teams. Provide guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level. May influence the external environment through interactions with regulators, trade associations, and professional societies. Represent the QuRE function in Development governance forums, Global Written Standards Steering Committees/Community of Practice. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree or equivalent in scientific, engineering or quality-related field. Experience in the pharmaceutical industry and/or quality assurance, quality management or risk management. Leadership of one or more GCP/GVP/GLP Audit program management. Must have operated in a senior management role with supervisory/management experience. Experience leading global multidisciplinary, functional, line and matrix teams. Knowledge of drug development process, global and national regulatory requirements, especially ICH-GCP as well as analytical, organizational and planning skills. Knowledge of risk management and quality narratives. Leadership skills with demonstrated success in managing and developing high-performing teams. Experience managing key stakeholders. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in supporting regulatory authority inspections. Broad knowledge of risk-based quality management, root cause analysis and quality by design concepts and methodology. Broad knowledge of Asia drug development requirements, especially China and Japan. Digital savviness, experience with AI/ML and data analytics. Ability to work effectively in an international multicultural matrix organization. Effective communication/negotiation skills and customer management skills. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us on or . Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive. As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK . click apply for full job details
Jan 18, 2025
Full time
Senior Director Quality Business Partner: Clinical Development Sector: Audit Role: Senior Executive Contract Type: Permanent Hours: Full Time Site Name: UK - London - New Oxford Street, UK - Hertfordshire - Stevenage Posted Date: Nov Do you have a passion for developing and delivering a quality strategy for clinical development? If so, the Senior Director Quality Business Partner: Clinical Development role could be an exciting opportunity to explore. The Senior Director Quality Business Partner: Clinical Development is responsible for developing and delivering the quality strategy for the portfolio within the scope of Clinical Development. The position will develop methods to effectively and efficiently provide proactive quality support and consultation and drive quality into the business. The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK development processes are effective in ensuring the integrity of the data, compliance with external regulatory requirements and internal GSK requirements, and protection of patients. The Senior Director, QBP Clinical Development is a member of the Functional Process Quality Leadership team and, with other members of the LT, is responsible for the strategy and direction of this function. Responsibilities include: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include: Has direct accountability for the quality strategy for Asia Development, Clinical Operations and the Addenbrookes Clinical Pharmacology Unit (CUC). Build and lead a Quality team that provides experienced quality support for Asia Development, Clinical Operations and process-related projects and initiatives. Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs of the organization, regulatory requirements and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provide guidance and expectations to the business to build in quality by design and to enable the execution of external regulations and internal standards. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partners and executive management. Risk Assessment and Audit Strategy Oversee risk assessments for the audit universe within the area of responsibility, ensuring that high-risk areas are identified and prioritized for audits or other quality interventions. Provide input into the global audit plan based on identified signals/trends/risks/gaps. Inspection Readiness Foster a culture of inspection readiness by developing proactive quality strategies, leading inspection readiness initiatives, and supporting successful regulatory inspections. Leadership/People Management Build and maintain a Clinical Development Quality team by creating an environment that attracts, develops and retains high-quality employees. Knowledge Sharing and Quality Culture Promote a strong quality culture across the Development organization, emphasizing the importance of quality in achieving quality and business objectives. Champion the continuous improvement of quality systems and processes, fostering a culture of accountability, innovation and excellence. Cross-functional collaboration Collaborate closely with Clinical Operations, Asia Development, OCMO and other functions to ensure quality is integrated into clinical development strategies and operations. Serve as a trusted partner to senior leadership, providing expert guidance on quality risks, challenges, and opportunities related to clinical development. Other Lead multidisciplinary or cross-functional work/project teams. Provide guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level. May influence the external environment through interactions with regulators, trade associations, and professional societies. Represent the QuRE function in Development governance forums, Global Written Standards Steering Committees/Community of Practice. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree or equivalent in scientific, engineering or quality-related field. Experience in the pharmaceutical industry and/or quality assurance, quality management or risk management. Leadership of one or more GCP/GVP/GLP Audit program management. Must have operated in a senior management role with supervisory/management experience. Experience leading global multidisciplinary, functional, line and matrix teams. Knowledge of drug development process, global and national regulatory requirements, especially ICH-GCP as well as analytical, organizational and planning skills. Knowledge of risk management and quality narratives. Leadership skills with demonstrated success in managing and developing high-performing teams. Experience managing key stakeholders. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in supporting regulatory authority inspections. Broad knowledge of risk-based quality management, root cause analysis and quality by design concepts and methodology. Broad knowledge of Asia drug development requirements, especially China and Japan. Digital savviness, experience with AI/ML and data analytics. Ability to work effectively in an international multicultural matrix organization. Effective communication/negotiation skills and customer management skills. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us on or . Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive. As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK . click apply for full job details
You will need to login before you can apply for a job. Senior Product Director, Clinical Trial Design & Plan, GCO Analytics Site Name: GSK HQ, UK - London - New Oxford Street, Upper Providence, USA - Pennsylvania - Upper Providence Posted Date: Dec 9 2024 With R&D and Digital and Tech's (D&T) joint goals to supercharge data in R&D, this new role will be accountable for Digital and Tech products and services for R&D Global Clinical Operations (GCO), focusing on delivering the maximum value including helping to position GSK as 'Sponsor of Choice' for thousands of Clinical Investigators. GCO Function of GSK's R&D operationalizes ALL GSK Clinical Studies, from First time in human through Phase III/IV, operating in > 20 countries via thousands of Clinical Investigators (non-GSK staff) and tens of thousands of patients. Senior Product Director, Clinical Trial Design & Plan, GCO Analytics will lead a significant team with the below critical accountabilities and serve as Single Point Accountable Decision Maker (SPADM) relating to ALL R&D digital and tech aspects of Clinical Trial Design, Planning and enabling GCO-Wide analytics including AI/ML, as well as the tech products that support GCOs day to day operations. Key Responsibilities: D&T Strategy Definition & Governance: accountable to closely partner with GCO Leaders, translating strategic goals into actionable proposals, preparing and securing investment for value cases. Establish and lead Governance bodies, provide oversight and manage overall delivery, service performance and risk. Strategic Business Partnership: Serving as a full member of several GCO LT-1 Leadership Teams, contributing to D&T topics and driving strategic business discussions. End-to-End Accountability: for the lifecycle of all D&T systems used by Clinical Trial Design & Plan, and GCO Analytics, and associated tens of thousands of Clinical Investigators and patients in GSK Clinical Trials. Directly accountable for the delivery of all GCO DT investments, compliantly and to agreed KPIs, in partnership with GCO LT- 1s to ensure maximum value and business continuity. Product Management: Accountable for managing the product backlog and prioritizing all Tech services within their respective product domain, ensuring continuous feedback from business customers and end users. Vendor Management: Accountable for oversight of strategic partnerships with GSK Tech vendors (e.g., Accenture, TCS, Cognizant) as well as product-specific vendors, ensuring maximizing value and effective delivery of agreed value milestones. Matrix Management: Collaborating with other Digital and Tech functions (ex: GPT) to ensure delivery of key D&T services to GCO. Financial Management: Accountable for demonstrating rigor and discipline in managing budgets across the GCO D&T portfolio, ensuring effective allocation of resources, tracking financial performance, and optimizing spend to deliver maximum value. Quality, Risk & Compliance: Accountable for ensuring all products supporting the business are compliant with internal security, architecture, engineering, quality, risk management policies and practices. Line Management: Leading a team of Product Directors and Managers, providing guidance and mentorship. Note this role will likely account for 10-30% of the annual D&T DevCMO investment and has a significant opportunity to impact GSK pipeline via acceleration of GSK Clinical Trials, which will bring life changing medicines & vaccines to patients who are waiting for them. Basic Qualifications: Bachelor's Technical degree e.g., Computer Science, Engineering, Information Technology or Life-sciences 10+ years of Pharma experience in Clinical Trial Design, Plan and/or Analytics domain Demonstrated Experience of Stakeholder management and influence at VP/SVP level Demonstrated experience defining and delivering strategies that move the needle on critical KPIs via innovative technology solutions Demonstrated experience with Tech Product Management and delivery of scaled products that meet regulatory compliance obligations. (GxP) Leading Global Digital and Tech teams Preferred Qualifications: Experience in leading transformation through technology Broad awareness of Pharma and Tech industry Strong written and verbal communication skills Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Jan 18, 2025
Full time
You will need to login before you can apply for a job. Senior Product Director, Clinical Trial Design & Plan, GCO Analytics Site Name: GSK HQ, UK - London - New Oxford Street, Upper Providence, USA - Pennsylvania - Upper Providence Posted Date: Dec 9 2024 With R&D and Digital and Tech's (D&T) joint goals to supercharge data in R&D, this new role will be accountable for Digital and Tech products and services for R&D Global Clinical Operations (GCO), focusing on delivering the maximum value including helping to position GSK as 'Sponsor of Choice' for thousands of Clinical Investigators. GCO Function of GSK's R&D operationalizes ALL GSK Clinical Studies, from First time in human through Phase III/IV, operating in > 20 countries via thousands of Clinical Investigators (non-GSK staff) and tens of thousands of patients. Senior Product Director, Clinical Trial Design & Plan, GCO Analytics will lead a significant team with the below critical accountabilities and serve as Single Point Accountable Decision Maker (SPADM) relating to ALL R&D digital and tech aspects of Clinical Trial Design, Planning and enabling GCO-Wide analytics including AI/ML, as well as the tech products that support GCOs day to day operations. Key Responsibilities: D&T Strategy Definition & Governance: accountable to closely partner with GCO Leaders, translating strategic goals into actionable proposals, preparing and securing investment for value cases. Establish and lead Governance bodies, provide oversight and manage overall delivery, service performance and risk. Strategic Business Partnership: Serving as a full member of several GCO LT-1 Leadership Teams, contributing to D&T topics and driving strategic business discussions. End-to-End Accountability: for the lifecycle of all D&T systems used by Clinical Trial Design & Plan, and GCO Analytics, and associated tens of thousands of Clinical Investigators and patients in GSK Clinical Trials. Directly accountable for the delivery of all GCO DT investments, compliantly and to agreed KPIs, in partnership with GCO LT- 1s to ensure maximum value and business continuity. Product Management: Accountable for managing the product backlog and prioritizing all Tech services within their respective product domain, ensuring continuous feedback from business customers and end users. Vendor Management: Accountable for oversight of strategic partnerships with GSK Tech vendors (e.g., Accenture, TCS, Cognizant) as well as product-specific vendors, ensuring maximizing value and effective delivery of agreed value milestones. Matrix Management: Collaborating with other Digital and Tech functions (ex: GPT) to ensure delivery of key D&T services to GCO. Financial Management: Accountable for demonstrating rigor and discipline in managing budgets across the GCO D&T portfolio, ensuring effective allocation of resources, tracking financial performance, and optimizing spend to deliver maximum value. Quality, Risk & Compliance: Accountable for ensuring all products supporting the business are compliant with internal security, architecture, engineering, quality, risk management policies and practices. Line Management: Leading a team of Product Directors and Managers, providing guidance and mentorship. Note this role will likely account for 10-30% of the annual D&T DevCMO investment and has a significant opportunity to impact GSK pipeline via acceleration of GSK Clinical Trials, which will bring life changing medicines & vaccines to patients who are waiting for them. Basic Qualifications: Bachelor's Technical degree e.g., Computer Science, Engineering, Information Technology or Life-sciences 10+ years of Pharma experience in Clinical Trial Design, Plan and/or Analytics domain Demonstrated Experience of Stakeholder management and influence at VP/SVP level Demonstrated experience defining and delivering strategies that move the needle on critical KPIs via innovative technology solutions Demonstrated experience with Tech Product Management and delivery of scaled products that meet regulatory compliance obligations. (GxP) Leading Global Digital and Tech teams Preferred Qualifications: Experience in leading transformation through technology Broad awareness of Pharma and Tech industry Strong written and verbal communication skills Why GSK? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
You will need to login before you can apply for a job. Senior Director Quality Business Partner: Pharmacovigilance and Regulatory Site Name: UK - London - New Oxford Street, UK - Hertfordshire - Stevenage Posted Date: Nov Are you interested in developing and delivering quality strategies in Pharmacovigilance and Lifecycle Management, ensuring regulatory compliance and patient safety? If so, the Senior Director Quality Business Partner: Pharmacovigilance and Regulatory role could be an exciting opportunity to explore. The Senior Director, Quality Business Partner, Pharmacovigilance and Regulatory is responsible for developing and delivering the quality strategy for Pharmacovigilance and Lifecycle Management activities. The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK processes for managing safety data are effective in ensuring the integrity of the data, compliance with external regulatory requirements (EU PV Legislation, US FDA Regulations) and internal GSK requirements, and protection of patients. The position is a member of the Function & Process Quality Leadership team and with other members of the LT, responsible for the strategy and direction of this function. Responsibilities include This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Functional Expertise: Has direct accountability for the quality strategy for Safety, Regulatory and post marketing activities. Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provides input into the global audit plan based on identified signals/trends/risks/gaps. Provide guidance and expectation to the business to build in quality by design and to enable the execution of external regulations and internal standards. Interact with executive management (QPPV, LOC, ViiV, GRA, CPO) and cross-functional business partner to identify areas of greatest quality risks and obtain information and feedback relevant to improvement. Drives issue resolution. Work with Quality Analytics to define KPI, KQI and metrics needed for QuRE and stakeholders. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and executive management. Supports the preparation, execution and close out of health authority inspections. Ensures ongoing inspection readiness in the area of responsibility. Provides training to QuRE and Business Partners regarding GVP, Safety and Regulatory Quality. Leadership/People Management: Build and maintain a Pharmacovigilance & Lifecycle Management Quality team by creating an environment that attracts, develops and retain high-quality employees. Provides leadership, professional development, mentoring and coaching for direct and indirect reports, including talent planning and performance management. Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables. Others: Leads multidisciplinary or cross-functional work/project teams. Provides guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level. May influence the external environment through interactions with regulators, trade associations, and professional societies. Liaise with stakeholders in R&D to understand global and local needs and determine priorities. Provide input into acceptable standards for Pharmacovigilance and Life-Cycle Management activities. Member of Global Safety Oversight & Alignment team. Serves as a member of the Functional & Process Quality leadership team setting strategies and directions for the function. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree or equivalent in scientific or quality-related field. Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management. Experience in clinical, medical, pharmacovigilance or regulatory quality. Must have operated in a senior management role with extensive supervisory/management experience. Knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements. Experience leading global multidisciplinary, functional, line and matrix teams. Experience managing key stakeholders. Preferred Qualifications: If you have the following characteristics, it would be a plus: Broad working knowledge/expertise in principles and concepts of quality by design and risk management. Solid working knowledge in continuous improvement with a background in the appropriate tools. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective. Analytical mindset to develop effective quality strategies for dealing with current and future industry trends. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments. Effective communication/negotiation skills and customer management skills. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Jan 18, 2025
Full time
You will need to login before you can apply for a job. Senior Director Quality Business Partner: Pharmacovigilance and Regulatory Site Name: UK - London - New Oxford Street, UK - Hertfordshire - Stevenage Posted Date: Nov Are you interested in developing and delivering quality strategies in Pharmacovigilance and Lifecycle Management, ensuring regulatory compliance and patient safety? If so, the Senior Director Quality Business Partner: Pharmacovigilance and Regulatory role could be an exciting opportunity to explore. The Senior Director, Quality Business Partner, Pharmacovigilance and Regulatory is responsible for developing and delivering the quality strategy for Pharmacovigilance and Lifecycle Management activities. The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK processes for managing safety data are effective in ensuring the integrity of the data, compliance with external regulatory requirements (EU PV Legislation, US FDA Regulations) and internal GSK requirements, and protection of patients. The position is a member of the Function & Process Quality Leadership team and with other members of the LT, responsible for the strategy and direction of this function. Responsibilities include This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Functional Expertise: Has direct accountability for the quality strategy for Safety, Regulatory and post marketing activities. Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provides input into the global audit plan based on identified signals/trends/risks/gaps. Provide guidance and expectation to the business to build in quality by design and to enable the execution of external regulations and internal standards. Interact with executive management (QPPV, LOC, ViiV, GRA, CPO) and cross-functional business partner to identify areas of greatest quality risks and obtain information and feedback relevant to improvement. Drives issue resolution. Work with Quality Analytics to define KPI, KQI and metrics needed for QuRE and stakeholders. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and executive management. Supports the preparation, execution and close out of health authority inspections. Ensures ongoing inspection readiness in the area of responsibility. Provides training to QuRE and Business Partners regarding GVP, Safety and Regulatory Quality. Leadership/People Management: Build and maintain a Pharmacovigilance & Lifecycle Management Quality team by creating an environment that attracts, develops and retain high-quality employees. Provides leadership, professional development, mentoring and coaching for direct and indirect reports, including talent planning and performance management. Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables. Others: Leads multidisciplinary or cross-functional work/project teams. Provides guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level. May influence the external environment through interactions with regulators, trade associations, and professional societies. Liaise with stakeholders in R&D to understand global and local needs and determine priorities. Provide input into acceptable standards for Pharmacovigilance and Life-Cycle Management activities. Member of Global Safety Oversight & Alignment team. Serves as a member of the Functional & Process Quality leadership team setting strategies and directions for the function. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree or equivalent in scientific or quality-related field. Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management. Experience in clinical, medical, pharmacovigilance or regulatory quality. Must have operated in a senior management role with extensive supervisory/management experience. Knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements. Experience leading global multidisciplinary, functional, line and matrix teams. Experience managing key stakeholders. Preferred Qualifications: If you have the following characteristics, it would be a plus: Broad working knowledge/expertise in principles and concepts of quality by design and risk management. Solid working knowledge in continuous improvement with a background in the appropriate tools. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective. Analytical mindset to develop effective quality strategies for dealing with current and future industry trends. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments. Effective communication/negotiation skills and customer management skills. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Select how often (in days) to receive an alert: Head of V&A (Energy Portfolio Management, Analytics and Structuring) Requisition ID: 39185 Location: London Wall, GB, EC2M 5SQ About ENGIE UK ENGIE is a global leader in low-carbon energy supply and services. We have been active in the UK energy market for over 20 years, focusing on energy storage and renewable energy (solar, wind, biogas), while supplying energy to organisations of all sizes. We are reshaping the energy future by balancing economic performance with a positive impact on people and the planet. We are looking for individuals committed to turning our vision into reality. About GEMS GEMS (Global Energy Management and Sales) is one of ENGIE's global business units. Specialising in energy markets, GEMS ensures the competitiveness of ENGIE's business units and develops its own franchise with external customers through services related to risk management, energy asset optimisation, and trading. About the Role The Energy Management UK Business Platform (EM UK) is part of GEMS, operating in the UK. EM UK provides decarbonisation, optimisation, and risk management services for internal and external clients in the UK. As the Head of V&A, you will play a key role in leading our Energy Transition efforts and help us leverage our diversified portfolio. Your leadership will facilitate high-quality decision-making at all levels, from intraday half-hourly pricing to long-term strategic investments. By maintaining a focus on excellence and collaboration, you will drive performance and innovation across the board. As part of the Senior Leadership Team (SLT) for EM UK, you will contribute to setting the strategic roadmap for EM UK and ENGIE in the UK, aiming to be a leading energy transition utility by 2030 and beyond. The EM UK SLT focuses on client-centric approaches, digital advancement, and fostering collaboration within the team and across ENGIE. Main Responsibilities Portfolio Management: Manage assets using the GEMS ETRM system to forecast revenues and running regimes. Provide analysis and guidance on risk management strategies and execute agreed hedges. Market Analysis: Drive UK assumptions for Group Scenario modelling. Develop and maintain market models to support asset investment and M&A activity. Quantitative Research and Modelling: Support traders and originators with innovative quantitative analysis. Design and build robust quantitative tools and deliver major strategic projects. Structuration: Implement structured products in the UK. Interaction Scope EM UK Team: Collaborate with various teams within EM UK. GEMS Expertise Centres: Engage with global Expertise Centres focusing on similar problems. Internal and External Clients: Work with Global Business Units and external clients on strategic and operational bases. External Bodies: Engage with NESO and represent ENGIE at industry forums. Experience, Motivations, and Skills Demonstrated leadership capability Passion for the Energy Transition Understanding of commodity market fundamentals, preferably power Digital mindset with an understanding of agile ways of working Excellent written and spoken English Strong communication skills, with the ability to engage clients and colleagues Collaborative and analytical approach to problem-solving Nice to Have Experience in power & gas markets in the UK Understanding of Data Science methodologies Advanced understanding of risk management systems Familiarity with modern coding languages such as Python, R, or Julia University degree in a quantitative area (e.g., IT, engineering, mathematics, economics) Experience in Risk Management and/or Decarbonisation services Why ENGIE? At ENGIE, we are committed to fostering a diverse and inclusive workplace. We offer hybrid and flexible working arrangements, competitive benefits, and opportunities for professional growth. Join us in our mission to lead the energy transition and make a positive impact on the world. How to Apply To apply for this position, please upload your CV outlining your qualifications and experience. We look forward to hearing from you! Business Unit: GEMS Division: GEMS - BP UNITED KINGDOM Legal Entity: INTERNATIONAL POWER LTD. Contract Type: Permanent Job Type: Full-Time Professional Experience: Skilled ( >3 experience
Jan 18, 2025
Full time
Select how often (in days) to receive an alert: Head of V&A (Energy Portfolio Management, Analytics and Structuring) Requisition ID: 39185 Location: London Wall, GB, EC2M 5SQ About ENGIE UK ENGIE is a global leader in low-carbon energy supply and services. We have been active in the UK energy market for over 20 years, focusing on energy storage and renewable energy (solar, wind, biogas), while supplying energy to organisations of all sizes. We are reshaping the energy future by balancing economic performance with a positive impact on people and the planet. We are looking for individuals committed to turning our vision into reality. About GEMS GEMS (Global Energy Management and Sales) is one of ENGIE's global business units. Specialising in energy markets, GEMS ensures the competitiveness of ENGIE's business units and develops its own franchise with external customers through services related to risk management, energy asset optimisation, and trading. About the Role The Energy Management UK Business Platform (EM UK) is part of GEMS, operating in the UK. EM UK provides decarbonisation, optimisation, and risk management services for internal and external clients in the UK. As the Head of V&A, you will play a key role in leading our Energy Transition efforts and help us leverage our diversified portfolio. Your leadership will facilitate high-quality decision-making at all levels, from intraday half-hourly pricing to long-term strategic investments. By maintaining a focus on excellence and collaboration, you will drive performance and innovation across the board. As part of the Senior Leadership Team (SLT) for EM UK, you will contribute to setting the strategic roadmap for EM UK and ENGIE in the UK, aiming to be a leading energy transition utility by 2030 and beyond. The EM UK SLT focuses on client-centric approaches, digital advancement, and fostering collaboration within the team and across ENGIE. Main Responsibilities Portfolio Management: Manage assets using the GEMS ETRM system to forecast revenues and running regimes. Provide analysis and guidance on risk management strategies and execute agreed hedges. Market Analysis: Drive UK assumptions for Group Scenario modelling. Develop and maintain market models to support asset investment and M&A activity. Quantitative Research and Modelling: Support traders and originators with innovative quantitative analysis. Design and build robust quantitative tools and deliver major strategic projects. Structuration: Implement structured products in the UK. Interaction Scope EM UK Team: Collaborate with various teams within EM UK. GEMS Expertise Centres: Engage with global Expertise Centres focusing on similar problems. Internal and External Clients: Work with Global Business Units and external clients on strategic and operational bases. External Bodies: Engage with NESO and represent ENGIE at industry forums. Experience, Motivations, and Skills Demonstrated leadership capability Passion for the Energy Transition Understanding of commodity market fundamentals, preferably power Digital mindset with an understanding of agile ways of working Excellent written and spoken English Strong communication skills, with the ability to engage clients and colleagues Collaborative and analytical approach to problem-solving Nice to Have Experience in power & gas markets in the UK Understanding of Data Science methodologies Advanced understanding of risk management systems Familiarity with modern coding languages such as Python, R, or Julia University degree in a quantitative area (e.g., IT, engineering, mathematics, economics) Experience in Risk Management and/or Decarbonisation services Why ENGIE? At ENGIE, we are committed to fostering a diverse and inclusive workplace. We offer hybrid and flexible working arrangements, competitive benefits, and opportunities for professional growth. Join us in our mission to lead the energy transition and make a positive impact on the world. How to Apply To apply for this position, please upload your CV outlining your qualifications and experience. We look forward to hearing from you! Business Unit: GEMS Division: GEMS - BP UNITED KINGDOM Legal Entity: INTERNATIONAL POWER LTD. Contract Type: Permanent Job Type: Full-Time Professional Experience: Skilled ( >3 experience
About Fuse Energy Fuse Energy is a forward-thinking company on a mission to redefine how energy solutions reach and engage customers. As we scale our operations, we seek a technically adept Head of Growth Engineering to lead our efforts in building an advanced, performance-focused growth engine. Role Overview The Head of Growth Engineering will be a pivotal figure in shaping and executing Fuse Energy's growth strategies. This role blends the worlds of engineering, marketing, and data science to build an agile, high-performance engine that drives customer acquisition and maximizes revenue generation through sophisticated, tech-driven approaches. You will manage and optimize systems that support targeted, data-backed marketing initiatives, enabling the company to make real-time, data-driven decisions and scale effectively. This position requires a deep understanding of both marketing principles and technical engineering concepts. You will collaborate closely with the growth and product teams to ensure seamless integration of technology with business goals. The ideal candidate will have a strong engineering background and the ability to work across technical and non-technical domains to drive impactful outcomes. Key Responsibilities Develop and execute a growth engineering strategy that aligns with Fuse Energy's business objectives and revenue targets. Balance long-term innovation with short-term, data-backed optimization for immediate growth. Build and maintain technical infrastructure for performance marketing. Oversee the ongoing development and enhancement of algorithms, automation tools, and AI-driven processes that streamline and improve the effectiveness of our marketing efforts. Champion a data-centric approach to decision making, ensuring that all growth activities are backed by robust data and analytics. Stay ahead of industry trends, particularly in AI, machine learning, and digital marketing technologies, to continuously innovate and keep Fuse Energy at the forefront of the energy sector. Minimum Qualifications Bachelor's or Master's degree in Computer Science, Engineering, or a related technical field. Professional experience in engineering, with a focus on the creative industry (marketing experience not needed). Ability to work with complex technical concepts and apply them to a creative field. Proven experience leading high-performing teams in a fast-paced environment. Strong communication skills and the ability to motivate, influence, and guide technical and non-technical teams alike. A natural problem solver with the ability to think critically and strategically to tackle complex challenges. Benefits Competitive salary and a stock options sign-on bonus. Biannual bonus scheme. Fully expensed tech to match your needs! 30 days paid annual leave per year (including bank holidays). Deliveroo breakfast and dinner for office-based employees.
Jan 18, 2025
Full time
About Fuse Energy Fuse Energy is a forward-thinking company on a mission to redefine how energy solutions reach and engage customers. As we scale our operations, we seek a technically adept Head of Growth Engineering to lead our efforts in building an advanced, performance-focused growth engine. Role Overview The Head of Growth Engineering will be a pivotal figure in shaping and executing Fuse Energy's growth strategies. This role blends the worlds of engineering, marketing, and data science to build an agile, high-performance engine that drives customer acquisition and maximizes revenue generation through sophisticated, tech-driven approaches. You will manage and optimize systems that support targeted, data-backed marketing initiatives, enabling the company to make real-time, data-driven decisions and scale effectively. This position requires a deep understanding of both marketing principles and technical engineering concepts. You will collaborate closely with the growth and product teams to ensure seamless integration of technology with business goals. The ideal candidate will have a strong engineering background and the ability to work across technical and non-technical domains to drive impactful outcomes. Key Responsibilities Develop and execute a growth engineering strategy that aligns with Fuse Energy's business objectives and revenue targets. Balance long-term innovation with short-term, data-backed optimization for immediate growth. Build and maintain technical infrastructure for performance marketing. Oversee the ongoing development and enhancement of algorithms, automation tools, and AI-driven processes that streamline and improve the effectiveness of our marketing efforts. Champion a data-centric approach to decision making, ensuring that all growth activities are backed by robust data and analytics. Stay ahead of industry trends, particularly in AI, machine learning, and digital marketing technologies, to continuously innovate and keep Fuse Energy at the forefront of the energy sector. Minimum Qualifications Bachelor's or Master's degree in Computer Science, Engineering, or a related technical field. Professional experience in engineering, with a focus on the creative industry (marketing experience not needed). Ability to work with complex technical concepts and apply them to a creative field. Proven experience leading high-performing teams in a fast-paced environment. Strong communication skills and the ability to motivate, influence, and guide technical and non-technical teams alike. A natural problem solver with the ability to think critically and strategically to tackle complex challenges. Benefits Competitive salary and a stock options sign-on bonus. Biannual bonus scheme. Fully expensed tech to match your needs! 30 days paid annual leave per year (including bank holidays). Deliveroo breakfast and dinner for office-based employees.