Role Summary
Associate Director, Content Approval for Vaccines. You will ensure global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance, adhering to internal GSK standards and ABPI/code regulations. This role involves collaborating across a highly matrixed organization including Commercial, Legal, Medical Affairs, Regulatory Affairs, Clinical Development, and third-party suppliers at a global level. Location: UK β London; Belgium β Wavre; Durham; Philadelphia; Upper Providence.
Responsibilities
- Primary medical reviewer and/or approver who is accountable for the thorough, timely review and approval of global promotional and non-promotional materials.
- Ensure content is scientifically accurate, meets the scientific rigor, is fair-balanced, and complies with GSK standards and external regulations (including ABPI Code where relevant).
- Maintain a deep understanding of ABPI Code of Practice (as an AQP/Appropriately Qualified Person), regulatory requirements, industry standards, best practices, and the GSK interpretation/position to ensure consistent application while reviewing and/or approving global medical or commercial content in scope of ABPI.
- Strong understanding of the business strategies/unmet needs to ensure the content is aligned with current medical practices/guidelines, and the content is fit for purpose to the targeted audience.
- Work alongside MI counterparts and various business partners to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience and support other GMI&CA team activities
- Serve as a key point of contact for regulatory and legal teams during audits and inspections, providing documentation and insights as needed
Qualifications
- Required: Significant pharmaceutical industry experience
- Required: Significant Medical Affairs experience as a reviewer of content used in promotional and non-promotional settings
- Required: Experience with commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)
- Required: Strong understanding of content approval requirements including external regulations (e.g. ABPI Code)
- Required: Strong understanding of international Codes of Practice FDA, IFPMA, EFPIA, IPHA, ABPI, etc.
- Required: Experience with evaluation of clinical literature
- Preferred: Experience of working at both global and local country level
- Preferred: Experience working with global teams in a matrix environment
- Preferred: Experience in Vaccines
- Preferred: Ability to accurately evaluate and summarize complex scientific literature, real-world evidence, and other observational research studies for scientific evaluation needs by various customer types
Education
- Masterβs/Graduate Degree in Life Sciences or Healthcare