Senior Medical Writing Manager: Clinical Documents Lead

Alnylam Pharmaceuticals; United States; Remote; USD 146,000 - 198,000; Full time

Benefits offered by this job

Medical

Dental

Vision coverage

Life and disability insurance

Lifestyle reimbursement program

Flexible spending and health savings

401(k) with generous match

Paid time off

Wellness days

Holidays

Two company-wide recharge breaks

Generous family resources and leave

Job summary

Alnylam Pharmaceuticals seeks a Senior Manager, Medical Writing to lead the development of clinical documents and oversee contract writers across the clinical program. You will ensure compliance with regulations and SOPs while delivering high‑quality, on‑time documents.

You will collaborate with cross‑functional teams including Biometrics, Regulatory Affairs, and Clinical Operations, and provide SME guidance on document production and SOP maintenance.

Qualifications

• Bachelor’s degree in Life Science with writing expertise or English/Communications with science background.
• 6+ years as a medical writer in sponsor/CRO setting; experience with regulatory submissions (CTA/IND/NDA/BLA) is a plus.
• In‑depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development process.
• Track record of managing multiple projects in fast-paced environments with attention to detail.
• Experience overseeing contract writers; proficient with Microsoft Windows, Word, Excel, and PowerPoint.

Responsibilities

• Produce high quality and on-time writing deliverables.
• Independently plan, write, edit, and format key documents (protocols, IBs, CSRs, integrated summaries).
• Facilitate/manage review and finalization for documents by internal teams and external vendors.
• Represent Medical Writing on project teams and coordinate with Director for resourcing.
• Collaborate with Biometrics, Regulatory, Clinical Operations, and other functions; liaise with external stakeholders.
• Serve as SME for clinical documents and production.
• Contribute to SOP and template development and maintenance.

Skills

Medical writing

Regulatory submissions

eCTD formatting

Project management

Contract writer oversight

Microsoft Word/Office

Education

Bachelor’s in Life Science or English/Communications

Advanced degree or professional certification preferred

Tools

Word

Excel

PowerPoint

Job description

Alnylam Pharmaceuticals seeks a Senior Manager, Medical Writing to lead the development of clinical documents and oversee contract writers across the clinical program. You will ensure compliance with regulations and SOPs while delivering high‑quality, on‑time documents.

You will collaborate with cross‑functional teams including Biometrics, Regulatory Affairs, and Clinical Operations, and provide SME guidance on document production and SOP maintenance.