Senior Manager, Medical Review - Medical Affairs

Who we are looking for:

The Senior Manager, Medical Review will play a critical role in ensuring the accuracy, scientific integrity, and compliance of promotional and medical materials across therapeutic areas. This individual will lead and participate in the medical review process (MRC), providing subject matter expertise on scientific content while partnering closely with Regulatory, Legal, Commercial, and Medical Affairs colleagues.

The role requires strong attention to detail, expertise in interpreting complex data, and the ability to work in a fast-paced, cross-functional environment.

Key Responsibilities

Medical Review & Governance

• Serve as a core reviewer for promotional and scientific materials within the Medical, Legal, Regulatory (MRC) review process.
• Assess scientific accuracy, balance, and compliance of content across multiple channels (slide decks, digital assets, websites, training tools, publications, etc.).
• Ensure all materials adhere to company SOPs, industry standards, and regulatory guidelines.
• Collaborate with authors and project owners to address review comments and finalize content in a timely manner.
• Support inspection readiness and audit preparation for medical review processes.

Cross-Functional Collaboration

• Partner with Commercial, Regulatory, Legal, and Medical Affairs colleagues to enable efficient review and approval of materials.
• Provide scientific and clinical expertise to ensure clarity and credibility of messaging.
• Serve as a liaison between Medical Affairs and other functions to streamline review timelines and ensure consistency across materials.
• Support field medical and commercial teams by ensuring aligned, compliant resources are available for external engagement.

Process Excellence & Operations

• Contribute to continuous improvement of the MRC process, including SOP development, workflow optimization, and system enhancements.
• Help establish review metrics and dashboards to track performance and efficiency.
• Train internal stakeholders on best practices for medical content submission and review.
• Partner with vendors and agencies to ensure accurate, compliant submissions.

Skills & Competencies

• Strong scientific and analytical skills with ability to critically evaluate data.
• Attention to detail with a focus on accuracy, balance, and compliance.
• Excellent communication skills to clearly explain review decisions and collaborate with cross-functional colleagues.
• Strong organizational and project management skills; able to manage multiple review cycles simultaneously.
• Understanding of regulatory and compliance frameworks governing medical and promotional materials.
• Ability to influence and partner across functions in a collaborative, solutions-oriented way.

Education & Experience

• Advanced degree in life sciences (PharmD, PhD, MD, or equivalent) strongly preferred.
• 3-5 years of experience in Medical Affairs, Medical Communications, or Medical Review within the biotech/pharma industry.
• Direct experience with MLR/MRC processes and cross-functional review committees required.
• Familiarity with Veeva Vault PromoMats or similar review platforms preferred.
• Background in neurology, rheumatology, immunology, or related therapeutic areas a plus.