Director, Medical Writing
Karyopharm Therapeutics Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $200,000 - $220,000 per year
Job Level
About the role
- Write or supervise writing of complex clinical study−related documents, including protocols, protocol amendments, Investigator Brochures and clinical study reports to support Karyopharm clinical development programs
- Write or supervise writing of regulatory documents including health authority meeting requests, briefing books, regulatory filings including NDA, IND, and Assessment Aids for submissions, where applicable
- Ensure all content is high-quality and consistent with program strategy, and where possible provide recommendations for content enhancements and optimization for team consideration
- Adjudicate cross-functional feedback, drive consensus, and reconcile diverse viewpoints via stakeholder management and facilitating comment resolution forums
- Serve as mentor to other medical writers and leverage prior experience to help build capabilities and co-develop junior talent
- Champion and lead operational workstreams as subject-matter expert to develop new internal guidance and improved practices for other medical writers
- Working with the Head of Medical Writing, develop medical writing processes, standards, and innovative initiatives
- Solve problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve
- Coordinate review and approval of oncologic clinical study-related documents
- Contribute to creation and maintenance of templates and standard text for clinical documents
Requirements
- More than 7 years of Medical Writing experience with evidence of increasing responsibility/technical development
- Experience writing Clinical Overviews and Integrated Summary of Safety/Efficacy in BLA/NDA submissions to Health Authorities
- Experience in managing medical writers preferred
- Knowledge of regulations relevant to medical writing within oncology
- B.S. or equivalent degree in a scientific area
- Advanced degree (MS or PhD) preferred
- Ability to assess workload and suggest prioritization to senior staff
- Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and document reviewing software
- Ability to work on several projects in parallel balancing multiple and overlapping timelines
- Careful attention to detail and accuracy
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
Benefits
- Comprehensive benefits (medical, dental, vision, 401(k), and more)
- Equity
- Potential to receive annual target bonuses
- Wellness Program with a monthly stipend
- Generous PTO and Holidays
- Options for remote work
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical study protocolsregulatory documentsclinical overviewsintegrated summary of safetyBLA submissionsNDA submissionsoncology regulationscontent enhancementstakeholder management
Soft Skills
mentoringproblem-solvingconsensus buildingcommunicationattention to detailprioritizationcollaborationfacilitationleadershiporganizational skills
Certifications
B.S. in scientific areaMS degreePhD