Senior Manager, Medical Writing

The Role

The Senior Manager, Medical Writing will lead the planning, authoring, review, and quality control of regulatory documents, ensuring the delivery of scientifically rigorous, accurate, and submission-ready content. The successful candidate will collaborate effectively with cross-functional team members to drive alignment and prepare high-quality clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs).

In addition, the successful candidate may provide oversight of external medical writing resources and will contribute to advancing departmental processes and standards.

Responsibilities

• Employ scientific knowledge and analytical skills to author or oversee the authoring of high-quality, scientifically accurate clinical and regulatory documents which may include 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 consensus among stakeholders on document content and strategy
• Coordinate, develop, and ensure consistent messaging across clinical program(s)
• Represent the Medical Writing department on clinical study teams
• Perform and/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

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 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 (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

Salary Range

$170,000- $200,000 USD

Target Bonus: 15%

Exact compensation will vary based on skills, experience, and location.

Our Locations

Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.

Boulder, CO: Our Boulder location is home to Cogent's discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.

Our Offer To You

At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles.

Our benefits also include a 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, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.