Director, US & Global Medical Review

Insmed Incorporated•NJ Corporate Headquarters, NJ

10d•$185,000 - $252,500•Remote

About The Position

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: We’re looking for a Director, US & Global Medical Review on the Medical Affairs – Medical Information team to help us expand what’s possible for patients with serious diseases. Reporting to the Global Head of Medical Review, you’ll be responsible for medical and scientific review of all advertising, promotional, and externally facing medical materials for US and Global functions to ensure all content meets the highest standards for accuracy, scientific integrity, and compliance with relevant laws, regulations, and industry best practices. As a core member of the Medical Review Committee (MRC) and Commercial Review Committee (CRC), the Director, US & Global Medical Review partners closely with Regulatory Affairs, Legal, Compliance, Commercial, and Medical Affairs to enable compliant, high-quality, and timely review and approval of materials. This role requires a strategic medical leader who combines deep scientific expertise with a thorough understanding of promotional compliance, medical governance, and cross-functional collaboration in the pharmaceutical industry.

Requirements

Advanced scientific or medical degree (MD, PharmD, PhD) or equivalent.
10+ years of experience in the pharmaceutical/biotech industry.
At least 5 years in medical review related roles.
Strong understanding of all regulations applicable to promotional and non-promotional communications, globally and in the US (FDA, EFPIA, ABPI, etc.).
Prior experience on MLR/MRC/CRC teams.
Exceptional scientific, analytical, and written communication skills.
Proven ability to lead and influence cross-functional teams in a matrixed, fast-paced environment.
Strong organizational skills with the ability to manage multiple priorities and meet time-sensitive deadlines.
Demonstrated integrity, sound judgement, and unwavering commitment to ethical and compliance standards.

Nice To Haves

Experience supporting field medical (MSL) functions and medical content development strongly preferred.
Experience in respiratory therapeutic areas and rare diseases strongly preferred.
Proficiency with document management and review systems (e.g., Veeva Vault PromoMats and MedComms) strongly preferred.

Responsibilities

Lead the medical review of US and Global Commercial and Medical materials, including promotional campaigns, digital content, congress materials, patient and HCP education, and field medical resources, ensuring scientific accuracy, clinical relevance, fair balance, and compliance with relevant health authority regulations and industry codes (e.g., FDA, EFPIA, ABPI).
Provide authoritative medical and scientific expertise throughout the review process, including critical evaluation of statistical validity, levels of evidence, and alignment with current standards of care.
Apply deep understanding of disease state, mechanism of action, and evolving clinical practice to ensure communications are clinically relevant and communicated in a medically responsible manner.
Serve as the lead medical reviewer on MRC and CRC, exercising expert judgment to assess data presentations, efficacy and safety claims, and overall quality.
Deliver clear, evidence-based guidance that ensures compliant, high-quality, and timely approval of materials.
Ensure all communications comply with applicable FDA regulations and regional industry ethical codes, interpreting and applying FDA regulations and EFPIA & ABPI code to govern risk/benefit representation, fair balance, and responsible dissemination of scientific data.
Act as a strategic medical partner to Regulatory, Legal, Compliance, Commercial, and Medical Affairs teams by translating complex clinical data into accurate, compliant, and compelling narratives that support business objectives and maintain scientific integrity.
Engage early in content development and brand planning to influence scientific positioning, claims strategy, and evidence use. Provide proactive medical input to shape messages that are differentiated, data-driven, and compliant.
Partner with global brand and affiliate medical teams to maintain alignment in scientific narratives, key data statements, and product positioning, while enabling appropriate adaptation to regional and local regulations.
Promote excellence in medical review by fostering a culture of scientific integrity, compliance, and cross-functional collaboration.
Mentor peers and junior team members, building organizational capability in medical review best practices.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back