Senior Manager, Medical Writing

Responsibilities

• Author or oversee clinical and regulatory documents such as protocols, clinical study reports and IBs

• Facilitate document reviews and lead comment resolution meetings

• Coordinate consistent messaging across clinical programs

• Represent Medical Writing on clinical study teams

• Perform and manage quality control reviews of clinical and regulatory documents

• Collaborate with and manage contract writers

• Contribute to medical writing processes and adhere to SOPs

Requirements

• Bachelor's degree with 6+ years of Medical Writing experience, or advanced degree with fewer years

• Strong knowledge of FDA and ICH guidelines and GCP

• Proficient in interpreting data and summarizing scientific literature

• Excellent written, verbal and interpersonal communication

• Strong project and time management skills

• Proficiency with Word, Excel, PowerPoint, Adobe suite, Veeva RIM and SharePoint

Benefits

• Competitive salary, bonus and stock awards

• 100% of medical, dental and vision premiums covered

• 401(k) match with immediate vesting

• 12 weeks fully paid parental leave

About the Company

Cogent Biosciences is a publicly traded biotechnology company developing precision therapies for patients with unmet medical needs.