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
- MasterβΓΓ΄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