Senior Medical Writing Lead, Regulatory Docs & Oversight

Regulatory Toolkit; United States; On-site; USD 146,000 - 198,000; Full time

Job summary

Alnylam is seeking a Senior Manager, Medical Writing to lead the development of clinical documents in compliance with GCP, FDA regulations, and SOPs. You will oversee contract writers and partner with project teams to ensure timely, high-quality deliverables.

The role requires extensive experience in medical writing, regulatory submissions, and cross-functional collaboration across clinical development and regulatory affairs.

Qualifications

• Bachelor's degree in Life Science with writing expertise or English/Communications with science knowledge
• 6+ years as a medical writer in sponsor/CRO setting, regulatory submissions experience a plus
• Solid knowledge of GCP, FDA regulations, ICH guidelines, and drug development processes
• Proven ability to manage multiple projects in fast-paced environments
• Experience supervising contract writers; proficient with MS Office tools

Responsibilities

• Produce high quality, on-time medical writing deliverables
• Plan, write, edit, and format protocols, IBs, CSRs, and integrated summaries
• Manage review and finalization processes with internal and external stakeholders
• Represent Medical Writing on project teams and coordinate resourcing
• Collaborate with cross-functional teams and external vendors
• Serve as SME for clinical documents and SOP/template maintenance

Skills

Medical writing

Regulatory submissions

Project management

Editing

Communication

Education

Bachelor's in Life Science or English/Communications

Tools

Microsoft Word

Excel

PowerPoint

Windows

Job description

Alnylam is seeking a Senior Manager, Medical Writing to lead the development of clinical documents in compliance with GCP, FDA regulations, and SOPs. You will oversee contract writers and partner with project teams to ensure timely, high-quality deliverables.

The role requires extensive experience in medical writing, regulatory submissions, and cross-functional collaboration across clinical development and regulatory affairs.