Associate Director, Global & US Medical Review, Oncology

About the role

The Associate Director, Medical Review, will serve as a functional expert in the area of Medical Review for their assigned region and products and ensure alignment and integration of process and technology efficiencies in medical review activities across diseases areas for Global Medical Affairs Oncology (GMAO).

Responsibilities

• Provide advanced medical and scientific review of medical affairs materials and, promotional materials to support non-promotional and promotional review processes, as well as providing project management support for the medical review process, as needed.
• Provide advanced medical and scientific review of promotional and promotional materials with local and regional Regulatory codes applicable for the US region in mind. Experience with the ABPI, EFPIA, and EMEA codes is optional but preferred for this role.
• Develop and deliver ongoing Medical Review and MLR process training for internal groups and medical affairs teams to ensure compliance with policies and procedures.
• Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
• Develop content for the medical affairs booth in collaboration with GMAO stakeholders, as well as supporting third-party vendors. Provide advanced support to product booths at professional scientific meetings and congresses as appropriate. Participate in booth design and congress activities as required.
• Serve as the Medical Review subject matter expert on the Global Medical Strategy Team Oncology (GMSTO) meetings for the relevant products/ therapeutic areas.
• Design and implement internal communication plans to share metrics

Requirements

• PharmD/Doctorate with 5+ years of experience, OR, Masters degree in a scientific discipline with 7+ years of experience, OR Bachelor’s degree in a scientific discipline with 8+ years of experience, all plus commensurate long-term experience within pharmaceutical or biotech industry with a thorough grasp of the pharmaceutical industry
• 5+ years of healthcare or related experience (managed markets, clinical practice, research or academic) including 3+ years of medical review experience within the pharmaceutical industry
• Excellent written and oral communication skills
• Advanced PC skills, including MS Word, Excel, Power Point, and SharePoint
• Experience overseeing and managing budgets to ensure performance versus targets
• Oncology experience strongly preferred
• Firm understanding of pharmaceutical clinical development and product life cycle management
• Cross-functional team participation within the pharmaceutical or related industry

Preferred Requirements

• Advanced degree (PhD, PharmD or equivalent) in a scientific discipline is preferred
• Oncology experience strongly preferred