Senior Medical Writing Lead — Regulatory Strategy

Cogent Biosciences, Inc.; Waltham (MA); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Bonus

Stock awards

Medical, dental, vision premiums paid

401(k) match

Paid parental leave

Paid time off

Job summary

Cogent Biosciences, Inc. is seeking a Senior Manager, Medical Writing to lead planning, authoring, review, and QC of regulatory documents, ensuring submission-ready content. You will collaborate across functions to drive alignment and maintain high standards in accordance with GCP and SOPs.

The role may oversee external medical writing resources and contribute to department-wide process improvements, advancing Cogent’s bezuclastinib program and regulatory strategy.

Qualifications

• Bachelor’s degree with 6+ years of Medical Writing experience, or advanced degree (eg, PhD, MD, PharmD) with fewer years of Medical Writing experience
• Self-motivated and effective in working with cross-functional teams
• Proficient in researching and understanding scientific literature and distilling complex topics clearly and accurately
• Proficient in interpreting and critically analysing data and summarising it clearly and accurately
• Excellent interpersonal, written, and verbal communication skills
• Strong project management and time management skills
• Strong computer and software skills (eg, Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) and ability to learn new computer applications
• Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation

Responsibilities

• Lead planning, authoring, review, and quality control of regulatory documents to ensure submission-ready content
• Collaborate with cross-functional teams to drive alignment on document strategy and messaging
• Oversee external medical writing resources when needed and contribute to process improvements
• Represent Medical Writing on clinical study teams and ensure SOP adherence
• Perform quality control reviews of clinical and regulatory documents

Skills

Medical Writing

Regulatory documents

Cross-functional collaboration

Project management

Communication skills

FDA/ICH/GCP knowledge

Education

Bachelor’s degree in Life Sciences

Advanced degree (PhD/MD/PharmD)

Tools

Veeva RIM

SharePoint

Adobe suite

Microsoft Office

Job description

Cogent Biosciences, Inc. is seeking a Senior Manager, Medical Writing to lead planning, authoring, review, and QC of regulatory documents, ensuring submission-ready content. You will collaborate across functions to drive alignment and maintain high standards in accordance with GCP and SOPs.

The role may oversee external medical writing resources and contribute to department-wide process improvements, advancing Cogent’s bezuclastinib program and regulatory strategy.