Senior Director, Medical Writing - Oncology

Kura Oncology, Inc.; United States; On-site; USD 182,000 - 256,000; Full time

Benefits offered by this job

Competitive comp package

Bonus

401K + Employer contributions

Generous stock options

ESPP Plan

20 days of PTO to start

Holidays

Commuter Stipend (Boston Office)

In-Office Catered lunches

Home Office Setup

Lifestyle Spending Stipend

Job summary

Kura Oncology, Inc. seeks a Director of Medical Writing to lead regulatory documentation across clinical development. You will manage document strategy for IND/NDA/BLA filings, oversee external vendors, and ensure on-time delivery of high-quality submissions.

The ideal candidate has 10–12 years in medical writing within pharma/biotech/CRO, strong regulatory knowledge, and expert MS Word/Excel/PowerPoint skills. Oncology experience is preferred. Competitive package and annual target bonus offered.

Qualifications

• Bachelor's/Master's/PhD in life sciences or related field.
• Experience as a medical writer in pharma/biotech/CRO with 10–12 years.
• Experience authoring clinical study reports, protocols, and Investigator’s Brochure.
• Regulatory submissions experience a plus (clinical study reports).
• Strong knowledge of regulatory standards (FDA/ICH).
• Proven project management skills in medical writing.

Responsibilities

• Serve as SME on clinical regulatory documents across phases.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff to deliver high-quality documents on time.
• Adhere to regulatory standards (ICH-E3) and SOPs.
• Develop and maintain medical writing SOPs, templates, and work practices.
• Oversee vendors including writers, QC reviewers, and editors.
• Proficient in EndNote or RightFind Cite It for literature references.
• Stay current on industry trends in medical writing.
• Perform other duties as assigned by management.

Skills

Regulatory writing leadership

Cross-functional leadership

Timeline management

Attention to detail

Independent decision making

Oncology experience

Education

Science degree

MS/PhD preferred

Tools

EndNote/RightFind Cite It

MS Word

MS Excel

MS PowerPoint

MS Project

Documentum

Core Dossier

Veeva

ISI Writer

Liquent Smart Desk

Acumen Stylus

Job description

Kura Oncology, Inc. seeks a Director of Medical Writing to lead regulatory documentation across clinical development. You will manage document strategy for IND/NDA/BLA filings, oversee external vendors, and ensure on-time delivery of high-quality submissions.

The ideal candidate has 10–12 years in medical writing within pharma/biotech/CRO, strong regulatory knowledge, and expert MS Word/Excel/PowerPoint skills. Oncology experience is preferred. Competitive package and annual target bonus offered.