Director, Medical Writing & Regulatory Strategy

Regulatory Jobs; Boston (MA); On-site; USD 227,000 - 256,000; Full time

Benefits offered by this job

Generous benefits

Equity

Stock options

401K

PTO 20 days

Job summary

Kura Oncology is seeking a Director of Medical Writing to serve as a subject matter expert on clinical protocols, study reports, and regulatory documents. You will guide document strategy for regulatory submissions (IND/NDA/BLA) and manage external vendors, SOPs, and templates in a fast-paced biotech setting.

The role requires extensive experience in medical writing within pharma/biotech/CRO, strong knowledge of ICH and FDA regulations, and the ability to lead complex writing projects with

Qualifications

• Bachelor's/Master's/PhD in scientific or clinical field required, advanced degree preferred.

Responsibilities

• Prepare clinical regulatory documents through all phases of clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with cross-functional groups to deliver high-quality documents on time.
• Adhere to regulatory standards including ICH-E3 and SOPs.
• Manage external vendors and develop SOPs and templates.

Skills

Regulatory writing

Project management

Detail oriented

Editing for brevity

Cross-functional collaboration

Education

Bachelor's/Master's/PhD in scientific field

Masters or PhD preferred

Tools

EndNote or RightFind Cite It

MS Word

MS Excel

MS PowerPoint

MS Project

EDMS tools (Documentum/Core Dossier/Veeva)

Job description

Kura Oncology is seeking a Director of Medical Writing to serve as a subject matter expert on clinical protocols, study reports, and regulatory documents. You will guide document strategy for regulatory submissions (IND/NDA/BLA) and manage external vendors, SOPs, and templates in a fast-paced biotech setting.

The role requires extensive experience in medical writing within pharma/biotech/CRO, strong knowledge of ICH and FDA regulations, and the ability to lead complex writing projects with