Senior Manager, Medical Writing

Job Summary

Managing a team of medical writing professionals, the full-time Senior Manager, Regulatory and Medical Writing will oversee document preparation and regulatory submissions while working remotely in the US.

Key responsibilities

• Mentors and advises team members on regulatory updates and medical writing best practices
• Independently manages projects from inception to completion, ensuring quality and compliance with regulatory standards
• Handles client meetings and feedback, proactively addressing any issues or gaps in deliverables

Required qualifications

• College graduate in a scientific, medical, or clinical discipline; Master's or PhD preferred
• Minimum of 6 years of experience in Regulatory and Medical Writing or a related field
• Proven experience in managing and mentoring medical writing professionals
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Hands-on experience with clinical trial and pharmaceutical development preferred