Senior Manager, Medical Writing

Cogent Biosciences • Waltham, MA

4d

About The Position

The Senior Manager, Medical Writing will lead the planning, authoring, review, and quality control of regulatory documents, ensuring scientifically rigorous, accurate, and submission-ready content. The role collaborates with cross-functional team members to drive alignment and prepare high-quality clinical documents in accordance with applicable regulations, Good Clinical Practices, and company Standard Operating Procedures (SOPs). The successful candidate may oversee external medical writing resources and contribute to advancing departmental processes and standards.

Cogent Biosciences is a publicly traded biotechnology company developing precision therapies for patients with unmet medical needs. Its lead program, bezuclastinib, is designed to selectively inhibit KIT exon 17 mutations, including KIT D816V. The company describes promising initial data across trials in advanced systemic mastocytosis, non-advanced systemic mastocytosis, and gastrointestinal stromal tumors.

Requirements

• Bachelor’s degree and at least 6 years of Medical Writing experience, or an advanced degree (e.g., PhD, MD, PharmD) with fewer years of Medical Writing experience.
• Self-motivated and effective working with cross-functional teams.
• Proficient in researching and understanding scientific literature and clearly and accurately distilling complex topics.
• Proficient in interpreting and critically analyzing data and summarizing it clearly and accurately.
• Excellent interpersonal, written, and verbal communication skills.
• Strong project-management and time-management skills.
• Strong computer and software skills, including Word, Excel, PowerPoint, Adobe suite, Veeva RIM, and 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

• Author or oversee the authoring of high-quality, scientifically accurate clinical and regulatory documents, potentially including clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, Common Technical Document modules, and briefing books.
• Facilitate document reviews and lead comment-resolution meetings to achieve stakeholder consensus on document content and strategy.
• Coordinate, develop, and ensure consistent messaging across clinical programs.
• Represent the Medical Writing department on clinical study teams.
• Perform or manage quality-control reviews of clinical and regulatory documents as needed.
• Collaborate with and manage contract writers as needed.
• Contribute to the development and implementation of medical writing processes.
• Adhere to regulatory standards and company SOPs.
• Perform other medical-writing-related duties as assigned.

Benefits

• Competitive salary and bonus.
• Ongoing stock awards.
• Medical, dental, and vision premiums covered at 100% for employees and their families.
• Funding for up to 75% of in-network deductibles.
• 401(k) match with immediate vesting.
• Generous paid time off.
• 12 weeks of fully paid parental leave.
• Paid family and medical leave for all employees regardless of location.
• Company-paid short-term disability coverage for up to 20 weeks.
• Wellness programs.
• Tuition reimbursement.
• Inclusive family-forming support.
• Free on-site parking and gym facilities in the Waltham building.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior