Director, Medical & Regulatory Writing

The role

The Director, Medical Writing serves as a subject matter expert on clinical protocols, study reports, Investigator Brochures, and briefing books. This person will collaborate with cross-functional teams to deliver high quality documents and manage external vendors.

What you will do

• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Maintain current knowledge of industry trends and best practices for medical writing.
• Performs other duties as assigned.

Required qualifications

• Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field
• A minimum of 10-12 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment.
• Experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure.
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Ability to edit text for brevity and clarity.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Understanding of FDA and ICH regulations and guidelines
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.

Nice to have

• Masters or Phd degree
• Oncology experience
• Experience authoring and managing briefing books is a plus
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus

Benefits

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup

About the company

Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.