Director, Medical Review

Title: Director, US & Global Medical Review

Location: Remote

Full time

Job Description:

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.

What You'll Do:

In this role, you’ll have the opportunity to 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).  You’ll also:

• 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

Who You Are:

You have an advanced scientific or medical degree (MD, PharmD, PhD) or equivalent along with 10+ years of experience in the pharmaceutical/biotech industry, with at least 5 years in medical review related roles.  

You are or you also have:

• 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 Have (but not required):

• 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

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 domestic/international travel (approximately 10%–20%)

#LI-Remote

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Pay Range:

$185,000.00-252,500.00 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