Associate Director, US Medical Review

Role Summary

The Associate Director, US Medical Review will oversee the medical review of promotional materials and lead a dedicated indication sub-team within the US Medical Review Community. This role ensures scientific accuracy and cross-functional collaboration across Medical Affairs, Marketing, Legal, and Regulatory teams, and serves as the Medical Review lead for co-creation during material development with Marketing.

Responsibilities

• Lead an indication sub-team of Medical Reviewers within the US Medical Review Community, ensuring promotional materials are scientifically accurate, truthful, and compliant with regulatory standards.
• Provide solutions-oriented feedback and collaborate effectively with cross-functional stakeholders.
• Represent the Medical Review function in Medical Affairs matrix meetings to support strategic decision-making.
• Identify and implement process efficiencies within the Medical Review sub-team.
• Maintain up-to-date scientific knowledge, including product labeling, therapeutic areas, treatment guidelines, publication plans, and competitive landscape.

Skills

• Strong ability to critically evaluate scientific literature and interpret complex data.
• Excellent written and verbal communication skills tailored to diverse audiences.
• Proven ability to manage multiple projects, solve problems, and meet deadlines.
• Effective collaborator in a matrixed environment with a proactive and flexible mindset.
• Working knowledge of FDA regulations relevant to promotional and medical review.

Qualifications

• Doctorate degree (PharmD, MD, or PhD).
• 5+ years of experience in pharmaceutical or biotechnology industry, primarily within Medical Affairs.
• At least 3 years of direct experience in promotional/medical review.
• Prior experience in Neurology or Rare Disease preferred.
• Strong scientific and medical communication skills required.

Education

• Doctorate degree (PharmD, MD, or PhD) required.