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Associate Director, Content Approval, Vaccines

GSK
Full-time
Remote friendly (Durham, NC)
United States
Medical Affairs

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Role Summary

Associate Director, Content Approval for Vaccines, responsible for ensuring global promotional and non-promotional materials are scientifically accurate, compliant, and aligned with ABPI and internal GSK standards. Collaborates across Commercial, Legal, Medical Affairs, Regulatory, Clinical Development, and third-party suppliers at a global level.

Responsibilities

  • Primary medical reviewer and/or approver accountable for thorough, timely review and approval of global promotional and non-promotional materials.
  • Ensure content is scientifically accurate, evidence-based, fair-balanced, and compliant with GSK standards and external regulations (including ABPI where relevant).
  • Maintain deep scientific and therapeutic expertise on assigned products and therapy areas.
  • Understand ABPI Code of practice (as an AQP) and GSK interpretation to ensure consistent application during review/approval of global content within ABPI scope.
  • Align content with business strategies and unmet needs to ensure it is fit for purpose for the target audience.
  • Collaborate with MI counterparts and business partners to ensure high-quality, audience-relevant content; provide timely feedback on third-party vendor materials and escalate if standards are not met.
  • Escalate content risks to appropriate leadership; stay updated on regulatory requirements and industry standards for continuous compliance.
  • Identify opportunities for continuous improvement in materials and activities quality and compliance.
  • Serve as a point of contact for regulatory and legal teams during audits/inspections, providing documentation as needed.
  • Participate in workstreams to develop best practices and improvements for the content approval process.
  • Contribute to content creation plans to ensure deliverables and timelines are realistic and achievable.
  • Support other GMI&CA team activities and onboarding of new team members as required.

Qualifications

  • Required: Masterβ€šΓ„Γ΄s/Graduate Degree in Life Sciences or Healthcare.
  • Required: 4+ years of pharmaceutical industry experience.
  • Required: 3+ years of Medical Affairs experience as a reviewer of content used in promotional and non-promotional settings.
  • Required: Experience with global promotion/medical activities in the pharmaceutical industry (promotion, medical education, external partnerships, advisory boards).
  • Required: Experience evaluating clinical literature.

Preferred Qualifications

  • Strong understanding of content approval requirements including external regulations (e.g., ABPI Code).
  • Strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI, etc.).
  • Ability to cope with pressure and meet tight timelines; experience across global and local country levels.
  • Experience working with global teams in a matrix environment; ability to collaborate, delegate, and foster teamwork.
  • Experience in vaccines.
  • Strong organizational, planning, and communication skills; ability to work independently and manage multiple projects.
  • Ability to evaluate and summarize complex scientific literature, real-world evidence, and observational studies for diverse customer types; communicate complex data concisely.
  • Customer-focused, with problem-solving and conflict resolution skills.