Associate Director/Director, Medical & Regulatory Writing

Summary

Join Kura Oncology, a leading biotech company committed to precision medicine for cancer treatment, and be part of a team making a meaningful impact. As a Regulatory/Scientific Writer, you will prepare and finalize clinical documents, collaborate with cross-functional teams, manage document review processes, and ensure adherence to regulatory standards. Success requires demonstrated excellence in drug discovery and development, a collaborative work style, and a commitment to integrity and grit. The ideal candidate will possess a strong understanding of drug development, clinical research, and regulatory guidelines. Kura offers a competitive compensation package, including generous benefits, equity, and a bonus program.

Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required
• Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochures
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
• Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission
• Ability to manage competing priorities in a fast-paced environment
• Excellent problem solving, organizational, and analytical critical thinking skills
• Excellent written and verbal communication skills
• Strong attention to detail related to consistency, grammar, syntax, and formatting
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat
• Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva
• Ability to travel up to approximately 10% of the time

Responsibilities

• Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents
• Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
• Works closely with the study team to reach consensus on timelines for deliverables
• Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs
• Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency
• May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents
• Maintain current knowledge of industry trends and best practices for regulatory and scientific writing
• Performs other duties as assigned

Preferred Qualifications

• PhD degree is preferred
• Oncology experience preferred
• Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus
• 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 is 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
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!