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Associate Director, Content Approval, Specialty/Gen Med

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

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Role Summary

Associate Director, Content Approval for Specialty/Gen Med. You will play a pivotal role in ensuring global promotional and non-promotional content meets high standards of quality, scientific accuracy, balance, and compliance, including ABPI code considerations. This role involves collaborating across a matrixed environment with Commercial, Legal, Medical Affairs, Regulatory Affairs, 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, rigorous, fair-balanced, and compliant with GSK requirements and applicable external regulations (including ABPI Code).
  • Maintain deep scientific and therapeutic expertise on assigned products and therapy areas.
  • Maintain understanding of ABPI Code of practice as an AQP and ensure consistent application when reviewing/approving content within ABPI scope.
  • Align content with business strategies and unmet medical needs to ensure it is fit for purpose for the targeted audience.
  • Collaborate with business partners to ensure content is high quality and audience-relevant; provide timely feedback on third-party content and escalate when standards are not met.
  • Escalate content risks to appropriate leadership as needed; stay current with evolving regulatory requirements and industry standards.
  • Identify issues and opportunities for continuous improvement in materials and activities; serve as a point of contact for regulatory and legal teams during audits/inspections.
  • Participate in workstreams to develop best practices and continuous improvement for content approval processes; contribute to content creation plans with realistic timelines.
  • 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: Understanding of global commercial and medical activities (promotion, medical education, external partnerships, advisory boards).
  • Required: Strong clinical literature evaluation skills.
  • Preferred: Strong understanding of ABPI Code and external regulations; experience with international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI).
  • Preferred: Ability to work under pressure with tight timelines; experience at global and local country levels; matrix team experience.
  • Preferred: Strong organizational, planning, communication, and collaboration skills; ability to manage multiple projects; ability to summarize complex scientific literature and present clearly.
  • Preferred: Customer-focus, problem solving, and conflict resolution skills.
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