
Senior Manager, Medical Writing
Who We Are:
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 patient's.
The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST. In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025. The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.
The Role:
- Employ scientific knowledge and analytical skills to author 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 round-table meetings to achieve consensus among stakeholders on document content and strategy
- Ensure consistent messaging across documents as appropriate
- 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
- Manager: 5+ years of medical writing experience; Sr. Manager: 7+ years of medical writing experience, or with fewer years of experience for individuals with an advanced degree [MS, PhD, MD, PharmD]
- Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation
- 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
- Strong project management and time management skills
- Excellent interpersonal, written, and verbal communication skills
- Self-motivated and effective in working with cross-functional teams
- Strong computer and software skills (eg, Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) and ability to learn new computer applications
- Experience as a key contributor or lead author for submissions of regulatory documents is preferred
Salary Range:
130,000 - 180,000 $USD
Apply for this job
*
indicates a required field