Kura Oncology is seeking an Associate Director, Medical & Regulatory Writing to lead regulatory document development, CTD oversight, and vendor management for oncology programs. This role demands a strong track record in regulatory writing, cross‑functional collaboration, and strict timeline management.
You will produce protocols, amendments, clinical study reports, Investigator’s Brochures, and plain-language summaries, ensure ICH‑E3 compliance, and coordinate with regulatory affairs, clinical
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Lead, Medical & Regulatory Writing
Kura Oncology · Boston, MA, USA ·
- Pay:
- 184.000 - 211.000
- Job type:
- Full Time