Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer.

Key Responsibilities

• Prepare regulatory documents including IND applications, clinical study protocols, and informed consent forms
• Provide guidance and support for document preparation and reviews within the organization
• Support electronic submissions of regulatory documents to the FDA and serve as a resource for new medical writers

Required Qualifications

• Bachelor's degree required; advanced degree preferred
• 5+ years of experience in a CRO or pharmaceutical environment
• 3+ years of regulatory medical writing experience, preferably in oncology
• Lead writer experience on at least three key regulatory documents
• Familiarity with eCTD modules and industry regulatory guidelines