Associate Director, Medical Information Operations
Company Description:
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 patients-first 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.
Recognitions:
Consistently Ranked Science’s 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. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s 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 Work-certified 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.
Overview:The Associate Director, Medical Information Operations, is responsible for managing the operational execution of the company’s Global Medical Information capabilities. In addition, this role oversees and manages the entire lifecycle of Medical Materials review and approval process.
This role ensures efficient coordination of the medical review committee (MRC) activities, compliance with company policies and regulatory standards, and maintains the quality and integrity of the review process.
Responsibilities: Medical Information- Develop and monitor metrics and KPIs related to medical information responses.
- Ensure appropriate internal communication regarding medical information activities.
- Assist with other Medical Information projects, as needed
- Collaborate with cross-functional teams to ensure alignment of medical information with overall medical affairs strategy and to ensure successful completion of shared activities.
- Recommend process improvements to enhance quality and productivity.
- Facilitate process improvements including streamlined governance to optimize handling of contact center inquiries
- Assist in managing Global Medical Information budget and vendors.
- Manage the scheduling of periodic review for medical information letters
- Manage and coordinate the lifecycle of Medical Materials, including submission, review, approval, and storage, ensuring compliance with Insmed retention policies.
- Review submitted Medical Materials for completeness and readiness for MRC review, verifying accuracy of metadata, supporting documents, and references.
- Assess and coordinate expedited reviews, functional reviews, and IRB/EC reviews, as needed.
- Coordinate the inclusion of ad hoc reviewers as requested by the MRC Chair or reviewers.
- Ensure proper documentation of MRC reviewer comments and approved materials in the company's document management system (e.g., Veeva).
- Manage the scheduling of periodic reviews for approved Medical Materials .
- Collaborate with cross-functional teams to set priorities for review, manage timelines and priorities to meet business needs, and schedule MRC meetings as needed.
- Train collaborators on the MRC process and document management system and support the MRC Chair in training cross functional collaborators on the MRC policy and work instructions.
- Develop and implement process improvements to enhance the efficiency and quality of the MRC review process.
- Generate reports on MRC activities and metrics for senior leadership.
- Assist colleague managing the RightFind Enterprise (RFE), our literature platform, with various responsibilities and support
Requirements:
- Bachelor's degree required; advanced degree in life sciences or related field preferred
- Minimum of 7 years of experience in the pharmaceutical/biotech industry, with at least 4 years in medical affairs, regulatory affairs, or related roles
- Strong understanding of regulatory guidelines for medical communications
- Excellent project management and organizational skills
- Proficiency with document management systems (e.g., Veeva)
- Outstanding communication and interpersonal abilities
- Ability to work effectively in a fast-paced, cross-functional environment
- Detail-oriented professional with strong process management skills and a deep understanding of medical affairs and regulatory requirements.
- Located within reasonable driving distance of Insmed headquarters in Bridgewater, NJ
- 10-20% Travel
Salary Range: 147000-206333
Compensation & Benefits:
At Insmed, we’re committed to investing in every team member’s total well-being, 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 time-off plans
- Competitive compensation package, including bonus
- Equity Awards (Long-Term Incentives)
- Employee Stock Purchase Plan (ESPP)
For more informaion on U.S. benefits click here.
Additional Information:
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 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.