Manager, Medical Writing (Remote) at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

Manager, Medical Writing (Remote)

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Manager, Medical Writing will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and will oversee the work of contract writers on the clinical program.

Summary of Key Responsibilities

• Produce high quality and on-time writing deliverables .
• Plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents.
• Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors .
• Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with Medical Writing Program Leads to ensure proper planning for upcoming project writing deliverables .
• Collaborate effectively with Data Sciences and Statistics, Clinical Operations, Clinical Development, Regulatory Affairs, Early Development, Program Management, Research, and Quality, as well as with external stakeholders .
• Serve as subject matter expert for clinical documents and their production .
• Contribute to SOP and template development and maintenance .

Qualifications

• Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred .
• 4 years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus .
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process .
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment .
• Impeccable attention to detail and ability to complete writing assignments in a timely manner with little to no oversight .
• Experience overseeing the work of contract writers is a plus .
• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint .

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.