Associate Director, Medical Review Committee Operations

Insmed Inc. • Bridgewater, NJ • 2d ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution of the company's Global We're looking for an Associate Director, Medical Review Committee Operations, on the Medical Review team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Medical Review Committee (MRC), you'll be responsible for managing the operational execution of the company's Global Medical Review Operations, overseeing the full lifecycle of the medical materials review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. By driving process excellence, governance, and cross-functional collaboration, you will support timely, compliant, and scientifically accurate communication of medical information that advances the company's rare disease mission.What You'll Do: Manage and coordinate the lifecycle of medical materials, including submission, review, approval, and archiving in compliance with company retention policies. Review submissions for accuracy, completeness, and readiness for MRC review; verify metadata, supporting documentation, and references. Ensure accurate documentation of reviewer comments, approvals, and version control in the company's document management system (e.g., Veeva). Manage periodic reviews of approved materials to maintain scientific accuracy and compliance. Collaborate with cross-functional teams to prioritize materials, manage timelines, and schedule MRC meetings to meet business needs. Provide training and guidance on MRC processes and systems; support the MRC Chair in educating stakeholders on policy and procedures. Serve as the operational point of contact for global-to-local handover of medical materials, ensuring consistency and scientific integrity in local adaptations. Develop, maintain, and enforce SOPs, work instructions, and governance frameworks related to the medical review of scientific and non-promotional materials. Drive initiatives to harmonize review processes across global and regional teams, ensuring consistency and alignment with regulatory and company standards. Generate and present metrics and reports on MRC activities and performance for senior leadership. Monitor and analyze operational performance data to identify trends and opportunities for continuous improvement. Oversee quality control and audit readiness, serving as a subject matter expert on medical review operations during internal and external inspections.Who You Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs, Regulatory Affairs, or related functions within the pharmaceutical or biotech industry.You also have: Minimum 3 years of direct experience managing or participating in promotional material or medical review committee processes. Proven expertise with electronic material review systems (e.g., Veeva PromoMats and/or MedComms) Strong understanding of applicable regulations governing promotional and non-promotional activities globally (FDA, EFPIA, ABPI, etc.). Demonstrated ability to lead in a matrix environment and manage complex workflows. * Except

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