Senior Manager, Medical Writing

Job Summary

Managing a team of medical writers, the full-time Senior Manager, Medical Writing will lead medical writing strategies for clinical and regulatory submissions while ensuring adherence to quality standards in a remote work environment.

Key responsibilities

• Oversees and mentors in-house and contract medical writing staff, ensuring high-quality deliverables
• Authors and edits key regulatory documents, including clinical study reports and Investigator's Brochures, in compliance with corporate and regulatory standards
• Engages with project teams to provide medical writing expertise and manages timelines and project information effectively

Required qualifications

• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in medical writing
• Proven expertise in developing clinical documents for global regulatory submissions
• Experience in supervisory or mentorship roles is preferred
• Strong project management skills and ability to work in a cross-functional team environment
• BA/BS in Life Science; a Master's degree is strongly preferred