Senior Manager, Medical Writing

The role

The Senior Manager, Medical Writing will lead the planning, authoring, review, and quality control of regulatory documents. This person will collaborate with cross-functional teams to prepare clinical documents in accordance with regulations, Good Clinical Practices, and SOPs.

What you will do

• Author or oversee the authoring of clinical and regulatory documents including protocols, reports, Investigator’s brochures, and briefing books
• Facilitate document reviews and lead comment resolution meetings
• Coordinate and ensure consistent messaging across clinical programs
• Represent the Medical Writing department on clinical study teams
• Perform or manage quality control reviews of documents
• Collaborate with and manage contract writers
• 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

Required 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
• Proficient in interpreting and critically analyzing data and summarizing it
• 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)
• Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes

Benefits

• Competitive salary, bonus, and ongoing stock awards
• 100% medical, dental, and vision premiums for employee and family
• Funding 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
• 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 building

About the company

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.