Senior Director, Medical & Regulatory Writing
Kura Oncology, Inc.
5 hours ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Essential Job Functions:
- Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
- Serves as subject matter expert in preparing clinical regulatory documents through all phases of clinical research.
- Represents medical writing in cross-functional team meetings.
- Collaborates with clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs to deliver high-quality documents on time.
- Adheres to regulatory standards, including ICH-E3 guidelines and company SOPs.
- Supports development, improvement, and maintenance of medical writing work practice documents, SOPs, and document templates.
- Oversees vendors including contract writers, QC reviewers, and document formatters.
- Proficient in EndNote or RightFind Cite It for literature citation and creation of reference lists in Word.
- Maintains current knowledge of industry trends and best practices for medical writing.
- Performs other duties as assigned.
Job Specifications / Qualifications:
- Bachelor’s, Master’s, or PhD in scientific/medical/clinical discipline or related field (Master’s or PhD preferred).
- Strong track record of people management and delegating work.
- 12+ years as a medical writer in pharma/biotech/CRO (oncology experience preferred).
- Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochure (briefing books is a plus).
- Experience with regulatory submissions (clinical study reports) to regulators is a plus.
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines (ICH/GCP plus).
- Project management skills; ability to manage complex writing projects with minimal supervision.
- Ability to edit for brevity and clarity; detail oriented.
- Ability to understand, interpret, and present complex clinical data.
- Ability to coordinate multiple documents and manage timelines.
- High independence in decision-making and problem solving.
- Leads strategic decision-making across programs; drives cross-functional alignment.
- Understanding of FDA and ICH regulations; familiarity with eCTD-compliant templates.
- Experience with document formatting tools (e.g., ISI Writer, Liquent Smart Desk, Acumen Stylus).
- Expert with MS Word; working knowledge of MS Excel, PowerPoint, and MS Project.
- Experience with EDMS (e.g., Documentum, Core Dossier, Veeva).
- Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
- Serves as subject matter expert in preparing clinical regulatory documents through all phases of clinical research.
- Represents medical writing in cross-functional team meetings.
- Collaborates with clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs to deliver high-quality documents on time.
- Adheres to regulatory standards, including ICH-E3 guidelines and company SOPs.
- Supports development, improvement, and maintenance of medical writing work practice documents, SOPs, and document templates.
- Oversees vendors including contract writers, QC reviewers, and document formatters.
- Proficient in EndNote or RightFind Cite It for literature citation and creation of reference lists in Word.
- Maintains current knowledge of industry trends and best practices for medical writing.
- Performs other duties as assigned.
Job Specifications / Qualifications:
- Bachelor’s, Master’s, or PhD in scientific/medical/clinical discipline or related field (Master’s or PhD preferred).
- Strong track record of people management and delegating work.
- 12+ years as a medical writer in pharma/biotech/CRO (oncology experience preferred).
- Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochure (briefing books is a plus).
- Experience with regulatory submissions (clinical study reports) to regulators is a plus.
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines (ICH/GCP plus).
- Project management skills; ability to manage complex writing projects with minimal supervision.
- Ability to edit for brevity and clarity; detail oriented.
- Ability to understand, interpret, and present complex clinical data.
- Ability to coordinate multiple documents and manage timelines.
- High independence in decision-making and problem solving.
- Leads strategic decision-making across programs; drives cross-functional alignment.
- Understanding of FDA and ICH regulations; familiarity with eCTD-compliant templates.
- Experience with document formatting tools (e.g., ISI Writer, Liquent Smart Desk, Acumen Stylus).
- Expert with MS Word; working knowledge of MS Excel, PowerPoint, and MS Project.
- Experience with EDMS (e.g., Documentum, Core Dossier, Veeva).