Senior Manager, Medical Writing

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling.

Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

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 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

Salary Range:

$170,000- $200,000 USD

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…