Associate Director, Content Approval, Vaccines in Durham

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 the fostering of 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.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Key Responsibilities: This role will provide you the opportunity to utilize your expertise in the scientific area, understanding of the internal business strategies, applicable GSK processes/policies, and the external regulations including the ABPI code of practice to ensure global content is compliant, accurate, up-to-date, and fit for purpose for external engagement. These responsibilities include the following:

• 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: We are looking for professionals with these required skills to achieve our goals:

• 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: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• 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).

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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

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.

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.