Conduct high-quality review of all promotional and non-promotional materials and activities according to internal SOPs, relevant Industry Codes of Conduct and external laws and regulations, with a particular focus on digital, multichannel, and on-demand related activities and materials. The incumbent will also provide training and advice to internal customers on medical review processes, codes of practice and regulations.
KEY DUTIES & RESPONSIBILITIES
- Support the development and review of promotional and non-promotional material in collaboration with the Commercial teams and Medical colleagues in accordance with all relevant regulations, industry voluntary codes of practice, and internalpolicies and procedures.
- • Support the optimisation of approval pathways for on-demand digital content. Collaborate closely with multichannel experts within Customer Excellence function.
- • Support the generation and presentation of metrics reports across all company medical review activities.
- • Ensure that materials have been discussed conceptually between therapy area assigned Medical personnel and the material initiators, prior to entering the materials review system.
- • Ensure adherence of all activities to company and regulatory requirements as well as industry voluntary codes of practice.
- • Provide training and guidance on industry/association guidelines and codes of practice to Medical and Commercial teams.
- • Support Commercial Teams by developing and leading training in collaboration with Medical colleagues and Learning.
- • Participate in and drive cross-functional approach to projects, process and product issues for digital, multichannel, and on-demand related activities and materials.
Education and Experience
- Pharmacy or Life Sciences (i.e. Pharmacology major) Degree
- Experience within the pharmaceutical industry within the area of Medical Information/Medical Affairs, including experience in the review of promotional/non-promotional material and product training would be advantageous.
Regulatory Processes - Applies knowledge of processes involved in submitting documents to regulatory bodies
Regulatory Expertise - Understands, applies, and complies with internal and external regulatory standards. Uses appropriate ethical, legal, and regulatory standards
Drive Execution - Focuses on results and motivates self and others to execute against commitments on time
Stakeholder Alignment - Serves as a common thread between diverse stakeholders to ensure alignment
Business Partnership - Champions business partnerships through mutual respect to achieve common goals; aligns to final decisions even if not in agreement
THE ALLERGAN COMMITMENT
Doing What is Right- Never jeopardize patient safety, product quality or complaince; always act with integrity
WAYS WE WORK
All For One AbbVie;We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.
Associate Director, Medical Affairs
ANZ Medical Affairs Team
Regulatory Affairs Team