Sr Director Medical Review Committee

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees and everything we do is motivated by a patientsfirst mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo solve problems and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration accountability passion respect and integrity we aim to foster an inclusive diverse and flexible work environment where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry come to Insmed to accelerate your career.

Consistently Ranked Sciences Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day our employees turn their passion for science and research into innovative solutions for patients. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences Top Employers survey for four years in a row.

A Certified Great Place to Work

We believe our company is truly special and our employees agree. In July 2024 we became Great Place to Workcertified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma Best Workplaces in New York PEOPLE Companies That Care Best Workplaces for Women Best Workplaces for Millennials and Best Medium Workplaces lists.

• Serve as Global Chair of the Medical Review Committee (MRC) overseeing medical review and approval of materials across regions to ensure accuracy compliance and alignment with corporate strategy.
• Develop and implement a longterm strategic vision for the MRC aligning with industry standards business needs and emerging regulatory trends.
• Accountable for keeping the global MRC SOP and work instructions current and ensuring alignment with standard methodologies and evolving regulatory mentorship (e.g. FDA OPDP EMA ICH PhRMA).
• Ensure harmonization and alignment of global regional and local MRC policies standard operating procedures (SOPs) and work instructions ensuring consistency while addressing countryspecific regulatory requirements.
• Provide guidance on complex medical and scientific content to ensure accuracy and appropriateness for the intended audience

• Maintain a governance framework that ensures all medical materials meet regulatory legal and ethical standards (e.g. FDA OPDP EMA ICH PhRMA).
• Serve as the primary MRC liaison with Quality and Compliance teams ensuring audit and inspection readiness by maintaining complete documentation training records and review histories.
• Monitor and assess regulatory trends affecting MRC operations proactively updating policies and procedures to mitigate risks and ensure compliance with global standards.

• Oversee the endtoend medical review process ensuring timely and efficient review of materials while maintaining high standards of scientific and medical integrity.
• Establish KPIs and performance metrics for the MRC and report insights to senior leadership on a monthly or asneeded basis.
• Explore and adopt digital solutions to improve the efficiency accuracy and scalability of the review process.
• Continuously evaluate and refine medical review workflows identifying gaps inefficiencies and opportunities for process improvements.

• Serve as the main liaison between MRC and customers such as Legal Regulatory Compliance Medical Commercial and senior leadership.
• Engage with Medical Affairs Commercial Development Operations Compliance and other internal customers to solve complex MRC issues and ensure alignment
• Lead crossfunctional working groups to refine and enhance review processes ensuring alignment with business objectives and evolving industry requirements.

• Collaborate with countrylevel MRC Chairs and Medical Information Operations roles ensuring effective governance at global and local levels.
• Develop and implement global training programs for MRC members equipping them with the necessary skills and knowledge to ensure consistent highquality reviews.
• Foster a culture of accountability collaboration and continuous learning mentoring team members and partners on standard methodologies in medical content review.

• Develop and implement a global training framework for MRC members ensuring consistency across regions.
• Build standardized training modules for new and existing MRC reviewers including Medical Legal Regulatory and Compliance partners.
• Ensure training content is aligned with global regulatory standards (FDA OPDP EMA ICH PhRMA) and internal SOPs.
• Regularly conduct training and mentor MRC members and other collaborators on the review process and standards.
• Maintain training records completion tracking and certification requirements in compliance with audit and inspection readiness.

• Develop and manage the annual budget for MRC operations ensuring costeffective resource allocation while maintaining highquality standards.
• Oversee vendor selection contracting and performance management for external partners supporting MRC functions
• Ensure vendors align with company policies regulatory requirements and contractual obligations proactively addressing performance or compliance concerns.
• Identify and implement costefficiency opportunities negotiate contracts and optimize resource utilization to improve impact.

• Stay ahead of regulatory and digital innovation trends integrating emerging technologies into MRC operations to enhance accuracy compliance and efficiency.
• Lead enhancements of Veeva Med Comms and other digital tools in collaboration with IT to optimize review processes.

• Bachelors degree in Life Sciences required; advanced degree preferred
• Minimum of 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in a Medical Affairs Medical Review Medical Information and/or Regulatory role
• Extensive knowledge of global regulatory and compliance standards (FDA OPDP EMA ICH PhRMA etc..
• Proven leadership in governing medical content review and ensuring compliance in a global matrixed organization.
• Extensive leadership background demonstrating the capability to foster crossfunctional teamwork coordinate with collaborators and craft decisionmaking at an executive level.
• Experience with audits inspections and risk mitigation strategies including interaction with Quality and Compliance teams.
• Budget management experience including resource planning cost optimization and vendor oversight.
• Experience with document management systems (e.g. Veeva) with preference for someone who has experience building and/or designing workflows and systems
• Experience using digital tools automation and solutions for medical content review.
• Diligent leader with a strong dedication to scientific integrity and regulatory compliance.
• Located within reasonable driving distance of Insmed headquarters in Bridgewater NJ
• 1020 Travel

At Insmed were committed to investing in every team members total wellbeing now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:

• Flexible approach to how we work
• Health benefits and timeoff plans
• Competitive compensation package including bonus
• Equity Awards (LongTerm Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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 atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase 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.