Associate Director, Content Approval, 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 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.

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 deep scientific and therapeutic expertise on assigned products and therapy areas

• Maintain a deep understanding of ABPI Code of practice (as an AQP/Appropriately Qualified Person) 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

• Provide timely feedback and recommendations for content created and/or reviewed by third-party vendors and escalate when third-party vendors do not meet the quality standards

• Address and/or escalate to appropriate leadership when content may result in a risk to the business

• Stay up to date with evolving regulatory requirements, industry standards, and best practices to ensure continuous compliance

• Identify issues, themes and/or opportunities for continuous improvement that enhance the quality and compliance of materials and activities

• Serve as a key point of contact for regulatory and legal teams during audits and inspections, providing documentation and insights as needed

• Actively participate in workstreams to develop best practices, ways of working and continuous improvement for promotional and non-promotional content approval process

• Actively contribute and provide input to content creation plans to ensure content deliverables and timelines are realistic and achievable

• Support other GMI&CA team activities (e.g. MI content creation, US medical review), when required and in onboarding new content approval team members.

Why You?

Basic Qualifications:

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

• Master’s/Graduate Degree in Life Sciences or Healthcare

• 4+ years of pharmaceutical industry experience 

• 3+ years of 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)

• Experience with evaluation of clinical literature

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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.

• Capable to cope with pressure and meet tight timelines

• Experience of working at both global and local country level 

• Experience working with global teams in a matrix environment

• Ability to work effectively with