Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer (Office or Remote).

Key Responsibilities

• Independently prepares and finalizes regulatory documents, including protocols and clinical study reports
• Coordinates comment adjudication meetings and manages project timelines
• Reviews documents and ensures adherence to regulatory requirements and internal standards

Required Qualifications

• Minimum of a Bachelor's and/or Master's degree in life sciences; PhD preferred
• Minimum of 4 years of Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment
• In-depth knowledge of industry regulations and ICH guidelines
• Experience with document management systems like Veeva Vault
• Familiarity with statistical analysis concepts preferred