Senior Manager, Medical Writing

Alnylam Pharmaceuticals•,

2d•$146,100 - $197,700•Onsite

About The Position

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.

Requirements

Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise
6+ years of experience as a medical writer in the sponsor and/or CRO setting
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
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

Nice To Haves

Advanced degree and/or professional certification/credentials preferred
Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus
Experience overseeing the work of contract writers is a plus

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