Associate Director, Content Approval, Vaccines

GSK • Upper Providence, PA

113d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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 others, delegate appropriately and foster a strong culture of teamwork.
• Experience in Vaccines.
• Strong organizational and planning skills.
• Strong communication and collaboration skills.
• Ability to work independently and manage/prioritize multiple projects simultaneously.
• 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.
• Ability to clearly communicate complex scientific data in a concise and accurate manner.
• Demonstrated customer-focus, problem solving abilities and strong conflict resolution skills.

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 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.

What This Job Offers

• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees