Associate Director, Content Approval, Vaccines

GSK

1d•Hybrid

About The Position

As an Associate Director, Content Approval for Vaccines, 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. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK 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:

Requirements

Master’s/Graduate Degree in Life Sciences or Healthcare
Significant pharmaceutical industry experience
Significant Medical Affairs experience as a reviewer of content used in promotional and non-promotional settings
Experience with commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)
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.
Experience with evaluation of clinical literature

Nice To Haves

Experience of working at both global and local country level
Experience working with global teams in a matrix environment
Experience in Vaccines
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

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 a deep understanding of ABPI Code of practice (as an AQP/Appropriately Qualified Person), regulatory requirements, industry standards, best practices, 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 MI counterparts and various business partners to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience and support other GMI&CA team activities
Serve as a key point of contact for regulatory and legal teams during audits and inspections, providing documentation and insights as needed