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Associate Director, Content Approval, Specialty/Gen Med

GSK
Full-time
Remote friendly (Collegeville, PA)
United States
Medical Affairs

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Role Summary

Associate Director, Content Approval for Specialty/Gen Med will play a pivotal role in ensuring global promotional and non-promotional content meets high standards of quality, scientific accuracy, balance, and compliance. The role involves adherence to internal standards and external regulations (including ABPI code) and collaboration across a matrixed environment including Commercial, Legal, Medical Affairs, Regulatory Affairs, Clinical Development, and third-party suppliers at a Global level.

Responsibilities

  • Primary medical reviewer and/or approver responsible for thorough, timely review and approval of Global promotional and non-promotional materials.
  • Ensure content is scientifically accurate, demonstrates proper levels of evidence, is fair-balanced, and complies with GSK standards and external regulations (including ABPI Code where relevant).
  • Maintain deep scientific and therapeutic expertise on assigned products and therapy areas.
  • Maintain understanding of ABPI Code of practice (as an AQP) and GSK interpretation to ensure consistent application when reviewing/approving global content in scope of ABPI.
  • Ensure content aligns with business strategies and current medical practices/guidelines; ensure content is fit for purpose for the targeted audience.
  • Collaborate with business partners to align and identify solutions to ensure high-quality content relevant to the audience.
  • Provide timely feedback to third-party vendors and escalate when vendors do not meet quality standards.
  • Address or escalate content risks to appropriate leadership.
  • Stay up to date with evolving regulatory requirements, industry standards, and best practices to ensure ongoing compliance.
  • 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, providing documentation and insights 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

  • Masterβ€šΓ„Γ΄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
  • Understanding of global commercial and medical activities in the pharmaceutical industry
  • Strong clinical literature evaluation skills

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 at both global and local country levels; matrix environment experience
  • Strong teamwork, delegation, and collaboration skills
  • Experience in Vaccines, Respiratory, Immunology, Hepatology, General Medicines, and Infectious Diseases
  • Strong organizational, planning, and communication skills
  • Ability to work independently and manage multiple projects simultaneously
  • Ability to evaluate and summarize complex scientific literature and real-world evidence for various customer types
  • Ability to communicate complex scientific data concisely and accurately
  • Customer-focused, problem-solving, and conflict resolution skills
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