Associate Director, Content Approval, Vaccines Job at NCBiotech in Durham

Overview 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.

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 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

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

Experience with commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)

Experience with evaluation of clinical literature

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, EFPIA, 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 Vaccines

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

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses incurred on your behalf for federal and state US transparency requirements. For more information, please visit the CMS Open Payments site.

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