Associate Director/Director, Medical & Regulatory Writing

Location

Boston, Remote (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, amendments, and investigator brochures. This role involves collaborating with cross-functional teams to interpret study results and ensure accuracy in documentation, adhering to regulatory standards like ICH-E3 and company SOPs.

Key Requirements

• Master's or advanced degree
• 7+ years of experience as a regulatory/scientific writer in biotech/pharma
• Proficiency in relevant software

Skills

• Strong communication skills
• Attention to detail
• Ability to manage competing priorities