Job Description The Therapy Area Specialist (TAS) plays a critical role in supporting compliance with local industry Codes of Conduct/Practice (Code) and internal policies through the rigorous review of promotional and non-promotional materials from both medical and regulatory perspectives within the assigned therapy areas. Acting as a strategic partner, you will provide expert advice, guidance and recommendations to both commercial and medical teams in the development, review and approval of materials for Australia and New Zealand. In addition to supporting Code challenges and offering local Code-related insights, you will foster strong partnerships with key stakeholders to drive process improvements, enhance collaboration and ensure alignment with AbbVie’s commitment to ethical and compliant communications that empower stakeholders and positively impact patient lives. NOTE: This is a 12 month contract opportunity. KEY DUTIES AND RESPONSIBILITIES Provide expert advice, guidance and training on the relevant processes, Code and regulatory requirements relating to review of promotional & non-promotional materials and activities for the assigned therapeutic portfolio. Conduct efficient and high-quality medical and regulatory review of materials according to internal SOPs and external laws, regulations, and Codes. Partner strategically with both Commercial and Medical teams, to support consistency with the necessary compliance standards, while aligning with the broader business and therapeutic strategy. Collaborate closely with internal stakeholders, fostering a partnership approach, and offering expert advice and recommendations to optimise content and ensure that 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. Includes attendance of regular TAS group meetings initiated by the Therapy Area Specialist Manager or the Head of Medical Affairs Communications. Provide specialised medical/scientific information support to the commercial teams in defence of the 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 the assigned therapeutic portfolio in collaboration with Medical colleagues and Product Managers. Participate in cross-functional approaches to projects and product issues within assigned therapeutic portfolio. Coordinate label update impact assessments to support the material owners and brands in the 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 specialised 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. Other ad hoc duties such as administrative duties, as requested.
