Associate Director, Content Approval, Specialty/Gen Med

As an Associate Director, Content Approval for Specialty/Gen Med, 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.

Key Responsibilities:

This role will provide you the opportunity to utilize your expertise in the scientific area, understanding of the internal business strategies, applicable GSK processes/policies, and the external regulations including the ABPI code of practice to ensure global content is compliant, accurate, up-to-date, and fit for purpose for external engagement.  These responsibilities include the following:

• 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 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.

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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
• Understanding of the typical commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)
• Strong clinical literature evaluation skills

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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 areas such as Vaccines, Respiratory, Immunology, Hepatology, General Medicines, and Infectious Diseases