Senior Medical Writing Leader - Regulatory Strategy & Docs

cogentbiosciences; Waltham (MA); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Stock awards

Medical, dental, vision coverage

401(k) match

Paid time off

Parental leave

Job summary

Cogent Biosciences in Waltham, MA, seeks a Senior Manager, Medical Writing to lead planning, drafting, reviewing, and QC of regulatory documents. You will collaborate with cross-functional teams to ensure scientifically rigorous, submission-ready content compliant with GCP, FDA, and SOPs.

The role may involve overseeing external medical writing resources, improving processes, and advancing departmental standards, with a focus on accuracy and timely delivery of high-quality documents.

Qualifications

• Bachelor's degree with 6+ years of Medical Writing experience, or an advanced degree (e.g., PhD, MD, PharmD).
• Strong cross-functional collaboration and time management skills.
• Proficient in researching literature and distilling complex topics clearly and accurately.
• Excellent interpersonal, written, and verbal communication skills.

Responsibilities

• Author or supervise high-quality clinical and regulatory documents including protocols, clinical study reports, and briefing books.
• Lead document reviews and resolve comments to reach consensus on content and strategy.
• Coordinate messaging across clinical programs and represent Medical Writing on study teams.
• Perform and oversee quality control reviews of documents as needed.
• Manage external writers and contribute to process improvements in medical writing.

Skills

Medical Writing

Cross-functional collaboration

Regulatory knowledge

Communication

Project management

Regulatory processes

Education

Bachelor's degree + 6+ years in Medical Writing

Advanced degree (PhD/MD/PharmD)

Tools

Word

Excel

PowerPoint

Adobe Suite

Veeva RIM

SharePoint

Job description

Cogent Biosciences in Waltham, MA, seeks a Senior Manager, Medical Writing to lead planning, drafting, reviewing, and QC of regulatory documents. You will collaborate with cross-functional teams to ensure scientifically rigorous, submission-ready content compliant with GCP, FDA, and SOPs.

The role may involve overseeing external medical writing resources, improving processes, and advancing departmental standards, with a focus on accuracy and timely delivery of high-quality documents.