Job Summary

A company is looking for a Director - Medical Writer.

Key Responsibilities:

• Lead and mentor the medical writing team, oversee project delivery for global clients
• Prepare and review various regulatory writing deliverables, negotiate timelines, and provide feedback
• Manage client relationships, provide scientific guidance, and ensure document quality and adherence to timelines

Required Qualifications:

• Bachelor's degree in a medical-related field or life science, post-graduate degree preferred
• 10-15 years of experience as a clinical/regulatory Medical Writer
• Experience in end-to-end CSR, IBs, Protocols across different TAs
• Understanding of drug development process and FDA regulations
• Experience in interacting with cross-functional study team members