Associate Director/Director, Medical & Regulatory Writing (Boston)

Company Name

Kura Oncology, Inc.

Job Description

The Associate Director/Director, Medical & Regulatory Writing prepares, edits, and finalizes clinical and regulatory documents such as synopses, protocols, investigator brochures, and submissions. Responsibilities include collaborating with cross-functional teams, managing document review processes, and ensuring timely delivery according to regulatory standards (ICH-E3, SOPs).

Requirements

• Master's or advanced degree in a scientific/medical discipline
• Minimum 7+ years as a regulatory/scientific writer in pharma/biotech/CRO
• Strong understanding of drug development and regulatory guidelines
• Oncology experience is preferred