Associate Director, Content Approval, Specialty / Gen Med
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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
- 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 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 to content created and / or reviewed by third-party vendors and escalate when third-party vendors do not meet 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.
- Participate in workstreams to develop best practices, ways of working and continuous improvement for the promotional and non-promotional content approval process.
- Contribute to content creation plans to ensure deliverables and timelines are realistic and achievable.
- Support other GMI&CA team activities when required and assist with onboarding new content approval team members.
Why You?
Basic Qualifications
Master’s / Graduate Degree in Life Sciences or Healthcare4+ years of pharmaceutical industry experience3+ years of Medical Affairs experience as a reviewer of content used in promotional and non-promotional settingsUnderstanding of the typical commercial and medical activities from a global perspective in the pharmaceutical industryStrong clinical literature evaluation skillsPreferred Qualifications
Strong understanding of content approval requirements including external regulations (e.g., ABPI Code)Strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI)Capable to cope with pressure and meet tight timelinesExperience of working at both global and local country levelExperience working with global teams in a matrix environmentAbility to work effectively with others, delegate appropriately and foster a strong culture of teamworkExperience in areas such as Vaccines, Respiratory, Immunology, Hepatology, General Medicines, and Infectious DiseasesStrong organizational and planning skillsStrong communication and collaboration skillsAbility to work independently and manage / prioritize multiple projects simultaneouslyAbility to evaluate and summarize complex scientific literature, real-world evidence, and other studies for scientific evaluation needsAbility to clearly communicate complex scientific data concisely and accuratelyDemonstrated customer-focus, problem solving abilities and strong conflict resolution skillsPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Seniority level
Not ApplicableEmployment type
Full-timeJob function
Marketing, Public Relations, and Writing / EditingIndustries : Pharmaceutical Manufacturing#J-18808-Ljbffr