Senior Manager, Medical Writing - Remote

Overview

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patients.

In Short

• Lead the planning, authoring, reviewing, and QC of clinical and regulatory documents.
• Collaborate with cross-functional SMEs and manage contract writers.
• Ensure high-quality, scientifically accurate documents.
• Facilitate document reviews and lead consensus meetings.
• Adhere to regulatory standards and company SOPs.
• Contribute to medical writing process development.
• Perform quality control reviews of documents.
• Represent the Medical Writing department on clinical study teams.
• Self-motivated with strong project management skills.
• Excellent communication skills required.

Requirements

• Bachelor’s degree required.
• 5+ years of medical writing experience for Manager; 7+ years for Sr. Manager.
• Strong knowledge of FDA and ICH guidelines.
• Proficient in researching and understanding scientific literature.
• Strong project management and time management skills.
• Excellent interpersonal, written, and verbal communication skills.
• Strong computer skills (Word, Excel, PowerPoint, Adobe suite).
• Experience as a key contributor for regulatory submissions preferred.

Benefits

• Competitive pay with performance-based bonuses.
• Stock options and comprehensive insurance coverage.
• Competitive time-off and a 401(k) plan.
• Commuter/parking benefits provided.
• Diverse and inclusive workplace environment.