Senior Manager, Medical Writing

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 146,100 - 197,700; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

401(k) with company match

Flexible spending and health savings accounts

Paid time off and wellness days

Job summary

Alnylam Pharmaceuticals, Inc. is looking for a Senior Manager in Medical Writing to develop clinical documents in compliance with regulations and oversee contract writers. The role requires collaboration across various teams to ensure timely and high-quality deliverables.

Candidates should have over 6 years of relevant experience, a degree in Life Science or English/Communications, and a strong grasp of medical writing standards. The position offers a competitive salary and a comprehensive benefits package.

Qualifications

• 6+ years of experience as a medical writer in a sponsor or CRO setting.
• Knowledge of FDA regulations and ICH guidelines.
• Experience with regulatory submissions is a plus.

Responsibilities

• Produce high quality and on‑time writing deliverables.
• Write, edit, and format clinical documents.
• Manage review and finalization process for documents.

Skills

Medical writing expertise

Project management

Regulatory knowledge

Attention to detail

Collaboration

Education

Bachelor's degree in Life Science or English/Communications

Advanced degree or professional certification preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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

Pay Range

$146,100.00 – $197,700.00

Benefits

Alnylam’s robust Total Rewards package is designed to support your overall health and well‑being. We offer comprehensive benefits including medical, dental, and vision coverage; life and disability insurance; a lifestyle reimbursement program; flexible spending and health savings accounts; and a 401(k) with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company‑wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well‑being reflects our belief that caring for our people fuels the impact we create together.

Equal Opportunity

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E‑Verify Employer.