Principal Medical Writer

Role Summary

Principal Medical Writer – REMOTE position responsible for the development and management of medical writing deliverables including protocols, IBs, CSRs, Clinical Summary Modules for regulatory submissions, and responses to regulatory authorities. Requires strong knowledge of regulatory requirements and ICH guidelines (E3, E6) and document management systems; capable of working independently with minimal supervision.

Responsibilities

• 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.
• Apply in-depth knowledge of medical writing and therapeutic area/investigational product to support clinical programs; represent medical writing on cross-functional teams.
• Produce high-quality and timely documentation in line with expectations; interpret and apply regulatory/compliance/scientific requirements.
• Establish and negotiate document timelines and strategies.
• Provide leadership to address requirements or issues related to document preparation and production; collaborate with colleagues across functions.
• Provide coaching or mentoring to junior members of the medical writing team on document planning, processes, content, and provide peer review as needed.
• Provide inputs for medical writing processes, standards, and initiatives.

Qualifications

• 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; advanced degree preferred.
• Clinical/Regulatory medical writing experience required
• High-quality English writing style; ability to independently interpret and present scientific data; understanding of statistical methods and analysis plans.
• Understanding of regulatory requirements and ICH guidelines (E3, E6); knowledge of document management systems.
• Familiar with style rules from the American Manual of Style.
• Strong interpersonal skills; ability to negotiate and influence in a cross-functional environment.
• Ability to manage multiple programs with competing timelines; fast-paced environment.
• Dynamic, self-starter with strong organizational and project planning skills; adaptable to change.
• Demonstrates Insmed values: Collaboration, Accountability, Passion, Respect, Integrity.
• Ability to interact successfully in a dynamic and culturally diverse workplace.