Medical Writer - Regulatory

Job Summary

A company is looking for a Medical Writer - Regulatory.

Key Responsibilities

• Assist in organizing non-clinical and clinical data for IND module 2 section
• Review reports from external contractors and write comprehensive reports
• Summarize information for various parts of the IND submission

Required Qualifications

• Minimum of 8 years of industry experience in medical writing
• Scientific background with experience in infectious disease and monoclonal antibodies
• Experience writing module 2s for INDs and regulatory dossiers
• Preferred PhD or advanced scientific degree
• 3-4 years of development or lab experience is a plus