Medical Writing Manager

OVERVIEW:
The 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 deliverables
• Independently 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 the Director of Medical Writing to ensure proper planning and resourcing for upcoming project writing deliverables
• Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, 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
• 6+ 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 with impeccable attention to detail and ability to complete writing assignments in a timely manner
• Experience overseeing the work of contract writers is a plus; must be proficient with Microsoft Windows, Word, Excel, and PowerPoint
• Ability 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 Excellence

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.