At AbbVie, we believe better health outcomes start with trusted information.
We're looking for a Medical Review Specialist to join our Medical Affairs team in Sydney for a 12 month Max Term Contract, 3 days per week, and play a pivotal role in ensuring the scientific accuracy, integrity and compliance of materials across our diverse therapeutic portfolio. This is a unique opportunity for a healthcare, scientific, medical affairs or regulatory professional who enjoys partnering with stakeholders, navigating complex decisions and influencing outcomes through expertise rather than authority.
You'll work at the intersection of Medical Affairs, Regulatory Affairs and Commercial, helping teams bring high-quality, compliant communications to healthcare professionals and patients across Australia and New Zealand.
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 team in driving a consistent approach to medical and industry code review across the business. Includes attendance of regular group meetings initiated by the Head of Medical Affairs Communications.
- Develop and maintain Code and review-process related internal resources, including SOPs and guidance documents to facilitate compliance and clarity for stakeholders
- 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.