Senior Medical Writing Lead - Clinical Documents & Strategy

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 146,000 - 198,000; Full time

Job summary

Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers across the clinical program and ensures timely, high-quality deliverables.

The candidate will plan, write, edit, and format key documents (protocols, investigator brochures, study reports, integrated safety summaries) and facilitate efficient review processes with consultants and vendors.

Qualifications

• Bachelor's degree required or higher; life science or English/communications with science knowledge.
• 6+ years as a medical writer in sponsor or CRO settings; regulatory submissions experience a plus.
• Strong knowledge of GCP, FDA regulations, ICH guidelines, and drug development processes.
• Experience overseeing contract writers is a plus; proficient with MS Office applications.

Responsibilities

• Produce high-quality, on-time writing deliverables.
• Independently plan, write, edit, and format protocols, brochures, summaries and related documents.
• Manage review and finalization processes for documents from internal and external stakeholders.
• Represent Medical Writing on project teams and coordinate with cross-functional groups.
• Serve as SME for clinical documents and contribute to SOP/template development.

Skills

Medical writing

Regulatory knowledge

Project management

Vendor oversight

Attention to detail

Education

Bachelor's degree in Life Science or English/Communications

Advanced degree or professional certification preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers across the clinical program and ensures timely, high-quality deliverables.

The candidate will plan, write, edit, and format key documents (protocols, investigator brochures, study reports, integrated safety summaries) and facilitate efficient review processes with consultants and vendors.