Senior Medical Writer & Regulatory Submissions Lead

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 172,000 - 233,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off and holidays

Wellness days

Job summary

Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program.

You will develop key clinical documents in accordance with GCP, FDA regulations, and SOPs, coordinate filings, mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions.

Qualifications

• Bachelor's degree in Life Science with writing expertise or English/Communications with science background; advanced degree/certifications preferred.
• 7+ years as a medical writer in sponsor/CRO setting; NDA/BLA/MAA submissions experience strongly preferred; CTA/IND experience a plus.
• Experience developing MW processes and standards is a plus.
• In-depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development processes.
• Proven ability to manage multiple projects in fast-paced, deadline-driven environments.
• Experience overseeing contract writers and familiarity with eCTD formatting and EDMS systems.

Responsibilities

• Produce high-quality clinical documents on time.
• Plan, coordinate, develop, update, and revise key documents (protocols, IBs, SCSR, summaries, informed consent forms, etc.).
• Lead supplemental filings, Type 2 Variations, rest-of-world submissions, and clinical responses.
• Provide medical writing leadership to project teams and coordinate with MW management for resourcing.
• Facilitate efficient review and finalization by internal staff and external writers.
• Collaborate with Biometrics, Clinical Operations, Development, QA, and external stakeholders.
• Contribute to templates and processes; train staff and contractors on MW processes.
• Assist line managers in training and development of junior staff.

Skills

Project management

Attention to detail

Cross-functional collaboration

Regulatory submissions awareness

Education

Bachelor's degree in Life Science or English/Communications

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

eCTD formatting

Job description

Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program.

You will develop key clinical documents in accordance with GCP, FDA regulations, and SOPs, coordinate filings, mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions.