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Check out JobsAI Associate Director/Director, Medical & Regulatory Writing (Boston)
Kura Oncology, Inc.
Job Overview
Prepares, edits, and finalizes synopses, protocols, regulatory documents. Collaborates with cross-functional teams to interpret study results. Manages document review, ensuring conflicting comments are addressed. Completes documents according to timelines, adhering to regulatory standards and company SOPs. Supports the development of regulatory writing work practice documents and SOPs. May assist in vendor oversight.
Requirements
- Requires a Masters or advanced degree
- 7+ years of industry experience as a regulatory/scientific writer
- Oncology experience preferred