Karyopharm Therapeutics Inc.

Content Writer

• 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

Director, Medical Writing