Senior Medical Writer & Regulatory Submissions Lead

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 172,000 - 233,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an experienced medical writer to lead the preparation and submission of clinical documents across programs, ensuring timely, high-quality deliverables and alignment with regulatory expectations.

You will coordinate with cross-functional groups, manage multiple projects, mentor junior staff, and help standardize MW processes as the team grows. This role offers a competitive US pay range, comprehensive benefits, and opportunities to contribute to RNAi cures.

Qualifications

• Bachelor's degree with writing expertise or English/Communications with science expertise.
• 7+ years as medical writer in sponsor/CRO; NDA/BLA/MAA submissions preferred; CTA/IND a plus.
• Some experience developing MW processes and standards.
• Deep knowledge of GCP, FDA regulations, ICH guidelines, and drug development.
• Proven track record managing multiple projects in fast-paced, deadline-driven environment.
• Knowledge of eCTD formatting and EDMS systems preferred.
• Experience overseeing contract writers.
• Impeccable attention to detail.
• Proficiency with MS Word, Excel, PowerPoint.
• Align with Alnylam Core Values.

Responsibilities

• Produce high-quality and on-time clinical documents
• Plan, coordinate, develop, update, and revise key documents (protocols, investigator brochures, clinical study reports, integrated summaries, etc.)
• Lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses
• Provide medical writing leadership to project teams and coordinate with MW management
• Facilitate review and finalization with internal/external writers
• Collaborate with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, PM, Research, Quality, and Communications, plus external stakeholders
• Develop and standardize MW templates and processes; train staff and contractors
• Assist line managers in training junior staff

Skills

Medical writing

Regulatory submissions

GCP knowledge

Project management

EDMS systems

eCTD formatting

MS Office

Contract writers oversight

Education

Bachelor's degree in Life Science

Advanced degree preferred

Tools

EDMS software

Job description

Alnylam Pharmaceuticals, Inc. is seeking an experienced medical writer to lead the preparation and submission of clinical documents across programs, ensuring timely, high-quality deliverables and alignment with regulatory expectations.

You will coordinate with cross-functional groups, manage multiple projects, mentor junior staff, and help standardize MW processes as the team grows. This role offers a competitive US pay range, comprehensive benefits, and opportunities to contribute to RNAi cures.