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.

 

	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.

 

The Associate Director, Medical Writing is responsible for the complete preparation, including but not limited to, the writing, reviewing, and editing of Protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Clinical Summary Modules for regulatory submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines, and basic knowledge of document management systems. They will be responsible for leading all medical writing activities of one or more clinical development program(s).

(Essential Role Responsibilities):

• Acts as the lead medical writer and responsible for the complete preparation of all documents for assigned clinical development programs. Performs hands-on authoring of critical documents.
• Provides leadership/document strategy at the program level. Plan and negotiate timelines.
• Critically reviews documents produced by internal and external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
• Serves as a subject matter expert, representing Medical Writing on cross-functional teams.
• Participates in appropriate development teams and internal strategy and operations meetings.
• Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process.
• Participates in the recruiting/hiring process, and development of direct reports (if applicable) including identifying learning/training opportunities and implementing development plans.

• BA/BS with minimum 7 years (or advanced degree with minimum 4 years) of writing experience in the biopharma industry across therapeutic areas required; advanced degree preferred
• Progressive experience in medical writing, including oversight/management of permanent and contract staff or CROs
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
• Successful track record of leading complex clinical / regulatory writing projects, such as NDA, BLA, etc
• Ability to think strategically; high degree of influencing skills in shaping and developing content and wording.
• Demonstrated negotiating skills and resourcefulness
• Demonstrated collaborative and cross-functional approach to delivering high quality results within timelines
• Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities
• Well organized with a strong attention to detail, clarity, accuracy, and conciseness
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Project)
• Understands clinical data and uses text, tables, and figures as appropriate to accurately and effectively convey key messages
• Must successfully exhibit Insmed’s five (5) core corporate competencies: Accountability, Collaboration, Integrity, Passion, and Respect
• Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace!

Travel:

• Occasionally domestic travel will be required (approximately 5%) if remote-based

#LI-Remote

#LI-Hybrid

 

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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 information on U.S. benefits click here.

 

 

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.