Associate Director, Content Approval, Vaccines

Associate Director, Content Approval for Vaccines

As an Associate Director, Content Approval for Vaccines, you will play a pivotal role in ensuring the global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance. This includes adherence to internal GSK standards and applicable external regulations, including a robust understanding of the ABPI code of practice. This role will involve fostering robust relationships and collaborations within a highly matrixed environment which includes but is not limited to Commercial, Legal, Medical Affairs, Regulatory Affairs, Clinical Development, and third-party suppliers at a Global level.

Key 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 (i.e., levels of evidence); is fair-balanced and meets the GSK requirements/standards/processes as well as complies with applicable external regulations (incl. 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.

Basic Qualifications & Skills

• Master's/Graduate Degree in Life Sciences or Healthcare.
• Significant pharmaceutical industry experience.
• Significant Medical Affairs experience as a reviewer of content used in promotional and non-promotional settings.
• Experience with commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards).
• Strong understanding of content approval requirements incl. external regulations (e.g., ABPI Code).
• Strong understanding of international Codes of Practice FDA, IFPMA, EFIPIA, IPHA, ABPI etc.
• Experience with evaluation of clinical literature.

Preferred Qualifications & Skills

• Experience of working at both global and local country level.
• Experience working with global teams in a matrix environment.
• Experience in Vaccines.
• 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.

Closing Date for Applications - 26th of February (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.