Associate Director, Content Approval, Specialty/Gen Med

GSK, Plc.•Durham, NC

46d

About The Position

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.

Requirements

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

Nice To Haves

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
Strong organizational and planning skills
Strong communication and collaboration skills
Ability to work independently and manage/prioritize multiple projects simultaneously
Ability to accurately evaluate and summarize complex scientific literature, real-world evidence, and other observational research studies for scientific evaluation needs by various customer types
Ability to clearly communicate complex scientific data in a concise and accurate manner
Demonstrated customer-focus, problem solving abilities and strong conflict resolution skills

Responsibilities

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.