Director, US & Global Medical Review
Insmed · Corporate Headquarters, NJ
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Insmed seeks a Director of US & Global Medical Review to lead scientific and regulatory evaluation of promotional and medical materials across global functions. This role ensures compliance with FDA, EFPIA, and ABPI standards while partnering across regulatory, commercial, and medical teams to maintain scientific integrity and clinical accuracy.
What they're looking for
- Advanced degree (MD, PharmD, PhD) or equivalent
- 10+ years pharmaceutical or biotech industry experience
- At least 5 years in medical review or related roles
- Deep knowledge of FDA, EFPIA, ABPI promotional regulations
- Prior MLR/MRC/CRC committee experience
- Exceptional written and verbal communication abilities
- Proven ability to lead cross-functional teams in matrixed environments
What you'll be doing
- Lead medical review of US and global promotional, digital, and educational materials for scientific accuracy and compliance
- Provide authoritative medical expertise on statistical validity, evidence levels, and alignment with clinical standards
- Serve as lead medical reviewer on MRC and CRC committees, assessing data presentations and safety/efficacy claims
- Partner strategically with regulatory, legal, compliance, and commercial teams to translate clinical data into compliant narratives
- Mentor team members and promote scientific integrity and best practices across medical review functions
Privacy & handoff
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