Manager, Medical and Scientific Writing

📋 Description

• Author regulatory documents including IND/NDA/BLA summaries, CSRs, DSURs, and protocols
• Lead planning, execution, tracking, and delivery of medical writing projects
• Perform peer reviews of clinical and scientific documents
• Recruit, train, motivate, and develop medical writing staff
• Establish departmental goals and monitor performance metrics and KPIs
• Support business development with cost estimates and proposals

🎯 Requirements

• Advanced degree in Clinical, Medical, or Life Sciences (PhD preferred)
• 11+ years medical writing in pharma clinical trial or research environment
• 2+ years project or people management experience
• Strong knowledge of GCP and ICH guidelines including ICH E3
• Proficiency with Microsoft Office and Adobe Acrobat
• Experience with TRS Toolbox pharma edition plugin

🎁 Benefits

• Performance-based bonus opportunity
• Medical, dental, and vision coverage
• Tuition reimbursement and fitness reimbursement
• Employee Assistance Program and pension plan
• Generous paid time off and sick leave
• Remote work from home anywhere in Canada