Senior Manager, Medical Writing
Cogent Biosciences•Waltham, MA
•$170,000 - $200,000
About The Position
The Senior Manager, Medical Writing leads 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 align on 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.
Requirements
- Bachelor’s degree with 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 at 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 applications.
- Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation.
Responsibilities
- Author or oversee authoring of 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 reach stakeholder consensus on content and strategy.
- Coordinate and develop 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 fully covered for the employee and family
- 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 at the Waltham location
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What This Job Offers
Job Type
Full-time
Career Level
Senior
