Principal Medical Writer

Insmed Inc. • Bridgewater, NJ • 11h ago

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 four 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:The Principal Medical Writer is a REMOTE position, responsible for the development and management of medical writing deliverables, including but are not limited to protocols and protocol amendments, Investigator's Brochures (IBs) and IB updates, clinical study reports (CSRs), Clinical Summary Modules for Regulatory Submissions, and responses to regulatory authorities. As a content expert, this individual has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems; is capable of working independently with minimal supervision.What You'll Do: Significant scientific contributor and subject matter expert in preparation of clinical documentation; serves as the medical writing point of contact for clinical study teams. May serve as the lead Medical Writer. Applies in-depth knowledge of medical writing and therapeutic area/investigational product to support clinical programs. Represents medical writing on cross-functional teams. Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines. Responsible for establishing and negotiating document timelines and strategies. Provides leadership to address requirements or issues related to document preparation and production. Works collaboratively with colleagues across functions to achieve results. Provides coaching or mentoring to junior members of the medical writing team on document planning, processes, content, and provides peer review as needed. Provides inputs for medical writing processes, standards, and initiatives.Who You Are: Equivalent to 3 years of experience with an advanced degree or 5 years of experience with a Bachelor's degree in Life Sciences or related field; advance degree preferred. Clinical/Regulatory medical writing experience is required Must demonstrate a high-quality writing style in the English language and have the ability to independently interpret and present scientific and clinical data, and to understand statistical methods and analysis plans. Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems. Familiar with style rules from the American Association Manual of Style. Strong interpersonal skills and the ability to negotiate and influence in a cross-functional environment to achieve results. Must be able to manage multiple and varied programs with competing and aggressive timelines, prioritize activities, and be able to succeed in a fast-paced environment. Dynamic, self-starter with excellent organizational and project planning skills, and be adaptable to change. Must demonstrate Insmed values: Collaboration, Accountability, Passion, Respect, Integrity * Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace #LI-RemotePay Range:$119,000.00-167,267.00 AnnualLife at InsmedAt 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

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