Associate Director/Director, Medical & Regulatory Writing

ESSENTIAL JOB FUNCTIONS:

The Director, Medical Writing, serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator Brochures, and briefing books. The Director, Medical Writing may also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. There will need to be a very strong understanding of document timelines as planning is critical.

• 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, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary 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 to ensure consistency and efficiency.
• 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 medical writing.
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Phd degree is preferred
• A minimum of 10-12 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. 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
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Owns decision-making for their functional area or program, including resolving complex issues and making trade-offs to achieve program objectives, with minimal escalation.
• Leads cross-functional collaboration for assigned programs, proactively driving alignment across stakeholders and resolving issues to support program execution.
• 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.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for an Associate Director is $182,000 - $211,000 and the Director level is $227,000 - $256,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.