Manager Medical Writing Job at Alnylam in Cambridge

Senior Manager, Medical WritingThe Senior 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.Responsibilities:Produce high quality and on-time writing deliverablesIndependently plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documentsFacilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendorsRepresent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the Director of Medical Writing to ensure proper planning and resourcing for upcoming project writing deliverablesCollaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholdersServe as subject matter expert for clinical documents and their productionContribute to SOP and template development and maintenanceQualifications: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 preferred6+ 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 plusIn-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development processSuccessful track record of managing multiple projects in a fast-paced and deadline-driven environment with impeccable attention to detail and ability to complete writing assignments in a timely mannerExperience overseeing the work of contract writers is a plus; must be proficient with Microsoft Windows, Word, Excel, and PowerPointAbility to travel approximately 10% is required; demonstrate clear alignment with Alnylam Core Values including Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for ExcellenceU.S. Pay Range $146,100.00 - $197,700.00