Director, Medical & Regulatory Writing

Kura Oncology, Inc.

. Serve as subject matter expert in preparing clinical regulatory documents through all phases of clinical research .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $182,000 - $256,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing for clinical regulatory documents, including IND and NDA/BLA filings, while adhering to ICH-E3 guidelines and federal regulations. Proven ability to manage complex writing projects, collaborate across teams, and maintain high-quality standards in document preparation.

Highest-signal resume keywords

Medical Writing ExpertiseRegulatory Submissions ExperienceProject Management SkillsOncology ExperienceStrong Understanding of ICH Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Report AuthoringProtocol AuthoringInvestigator’s Brochure AuthoringDocument FormattingEditing for Brevity and ClarityComplex Clinical Data InterpretationECTD ComplianceDocument Management Systems ProficiencyProficiency in EndNoteProficiency in MS Word

Soft Skills

Detail OrientedIndependent Decision MakingProblem SolvingCross-Functional CollaborationStakeholder Alignment

Tools & Technologies

ISI WriterLiquent Smart DeskAcumen StylusDocumentumCore DossierVeevaMS ExcelMS PowerPointMS ProjectRightFind Cite It

Industry Keywords

Clinical ResearchPharmaceuticalBiotechCROGood Clinical PracticesFederal RegulationsICH GuidelinesMedical AffairsClinical OperationsBiostatistics

About the role

Key responsibilities & impact

Serve as subject matter expert in preparing clinical regulatory documents through all phases of clinical research
Provide guidance on document strategy for complex regulatory dossiers, including IND and NDA/BLA filings
Represent medical writing in cross-functional team meetings
Collaborate with clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs teams to deliver high-quality documents on time
Adhere to ICH-E3 guidelines, federal regulations, and company SOPs
Develop, improve, and maintain medical writing work practice documents, SOPs, and document templates
Oversee external vendors, including contract writers, QC reviewers, and document formatters
Maintain current knowledge of industry trends and best practices for medical writing
Plan and manage document timelines
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s, Masters or PhD degree in scientific, medical, clinical discipline or related field is required; Masters or PhD degree is preferred
Minimum of 10–12 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment
Oncology experience preferred
Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures
Experience authoring and managing briefing books is a plus
Experience in regulatory submissions presented to regulatory authorities is a plus
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus
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
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 document formatting tools such as ISI Writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools
Expert with MS Word and solid working knowledge of MS Excel, MS PowerPoint, and MS Project
Experience using an EDMS such as Documentum, Core Dossier, or Veeva
Must have proficiency in EndNote or RightFind Cite It
Ability to own decision-making for the functional area or program, resolve complex issues, and make trade-offs with minimal escalation
Ability to lead cross-functional collaboration and proactively drive stakeholder alignment

Benefits

Comp & perks

Generous benefits package with a variety of plans available with a substantial employer match
Career advancement/development opportunities
Competitive compensation package
Annual target bonus
401K + employer contributions
Generous stock options
ESPP Plan
20 days of PTO to start
18 holidays, including Summer & Winter Break
Paid paternity/maternity leave
In-office catered lunches
Home office setup
Lifestyle spending stipend
Commuter stipend (Boston Office)
Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more