Oncology Medical Writer

Job Summary

A company is looking for a Senior Medical Writer (Oncology).

Key Responsibilities

• Prepare initial IND applications, clinical study protocols, investigator brochures, and clinical study reports
• Provide guidance and support for the preparation or review of manuals and training guidelines
• Support electronic submission 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/pharmaceutical environment
• 3+ years of regulatory medical writing experience, preferably in oncology
• Lead writer experience on at least 3 key regulatory documents
• Familiarity with eCTD modules and industry regulatory guidelines