Job Description
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.
- Exceptional organizational and project management skills with attention to detail.
- Strong communication and interpersonal skills and ability to navigate diverse stakeholder perspectives.
- Analytical mindset with the ability to identify process inefficiencies and implement improvements
Nice to have (but not required): - Advanced degree (PharmD, PhD, MD, or MS) in life sciences, pharmacy, or a related field preferred.
Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements This role requires occasional travel (approximately 10-20%)
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Pay Range: $164,000.00-213,000.00 Annual
Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Job Tags
Local area, Remote work, Flexible hours,