Medical Writer

Job Summary

A company is looking for an Oncology Medical Writer.

Key Responsibilities:

• Preparation of initial Investigational New Drug (IND) applications and amendments
• Development of clinical study protocols, investigator brochures, and clinical study reports
• Supporting electronic submission of regulatory documents to the FDA

Required Qualifications:

• Bachelor's degree required, advanced degree preferred
• 2+ years of relevant experience in a CRO/pharmaceutical environment
• Familiarity with industry principles of drug safety, regulatory guidelines, and oncology
• Effective knowledge of company and sponsor-specific SOPs
• Ability to manage critical issues on multiple projects simultaneously