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

Company Name

Kura Oncology, Inc.

Job Overview

The role involves preparing, editing, and finalizing clinical and regulatory documents such as synopses, protocols, amendments, and investigator brochures. Module 2 clinical summary experience is a plus.

Requirements

• Master's or advanced degree in a scientific/medical discipline
• 7+ years of experience as a regulatory/scientific writer in pharma/biotech/CRO, preferably with oncology experience
• Experience authoring clinical study reports and protocols
• Solid understanding of drug development, clinical research, CTD, and ICH guidelines