Associate Director, Content Approval, Specialty / Gen Med

Associate Director, Content Approval For 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 :

Preferred Qualifications :

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