Senior Regulatory Medical Writer

Job Summary

A company is looking for a Senior Regulatory Medical Writer.

Key Responsibilities

• Author and provide input on clinical documents such as study reports and protocols
• Write complex clinical and scientific documents including IBs, bioassay reports, INDs, and MAAs
• Review documents prepared by junior team members and may provide training and mentorship

Required Qualifications

• Bachelor's degree in a scientific field or equivalent; advanced degree preferred
• 5+ years of relevant experience in medical writing
• Experience in the pharmaceutical or CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Equivalent combination of education and experience may be considered