Medical Regulatory Advisor

Job Opportunity

We are seeking a highly skilled professional to join our team as a Therapy Area Specialist. This critical role involves supporting compliance with industry Codes of Conduct and internal policies through the review of promotional and non-promotional materials from medical and regulatory perspectives.

As a strategic partner, you will provide expert advice, guidance, and recommendations to commercial and medical teams in the development, review, and approval of materials. You will support Code challenges, offer local Code-related insights, and foster partnerships with stakeholders to drive process improvements and ensure alignment with AbbVie's commitment to ethical and compliant communications that empower stakeholders and positively impact patient lives.

• Provide expert advice, guidance, and training on processes, Code, and regulatory requirements relating to the review of promotional & non-promotional materials and activities.
• Conduct efficient and high-quality medical and regulatory review of materials according to internal SOPs and external laws, regulations, and Codes.
• Partner strategically with Commercial and Medical teams to support consistency with necessary compliance standards while aligning with the broader business and therapeutic strategy.
• Closely collaborate with internal stakeholders, fostering a partnership approach, and offering expert advice and recommendations to optimize content and ensure medical accuracy and regulatory compliance aspects are embedded in materials.
• Support the Therapy Area Specialist Manager in driving a consistent approach to medical and industry code review across the business.
• Provide specialized medical/scientific information support to commercial teams in defense of brands, including response to Code complaints and initiation of complaints.
• Support Commercial as well as Learning & Development teams with medical/scientific training associated with products within assigned therapeutic portfolio.
• Participate in cross-functional approaches to projects and product issues within assigned therapeutic portfolio.
• Coordinate label update impact assessments to support material owners and brands in relevant updates to product-related materials.
• Maintain up-to-date knowledge of developments in relevant regulatory and Code requirements, as well as the clinical/scientific body of evidence within assigned therapeutic portfolio.
• Provide second-line support if required, in the provision of specialized medical/scientific information to healthcare professionals and consumers.
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies, and promote a safe work environment at all times.
• Adhere to AbbVie's internal codes of conduct and compliance processes.

• Minimum 1 year in the pharmaceutical industry within a medical function or similar function.
• Experience in reviewing promotional and non-promotional materials.
• Pharmacy or Life Sciences Degree (e.g., Pharmacology major).
• Medicines Australia Code of Conduct Continuing Education Program (CEP) Accreditation - Program 1.
• Knowledge and understanding of the relevant Industry Codes of Conduct relating to review of promotional materials and activities.
• Critical and thorough appraisal of the scientific literature.
• Ability to search scientific information within the literature.
• Demonstrated ability for both problem solving and consolidation of medical facts and clinical data.
• Ability to effectively communicate medical and scientific information to audiences with varying medical/scientific understanding.
• Effective communication skills considering appropriate context, timing, and method.
• Strategic mindset with a focus on solutions.
• Ability to navigate and adapt to ambiguity and risk.