Karyopharm Therapeutics Inc.

Operations

• Provides strategic and operational support within GMP Quality and Quality Systems
• Leads training initiatives
• Provides vendors management support
• Drives process improvement
• Partners cross-functionally to support successful Quality operations
• Contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance
• Supports day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches
• Monitors operational activities and assesses continuous improvement within the QA operations
• Serves as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances
• Facilitates root cause / A3 problem solving and partners with business partners on deviations/CAPAs (close on time, prove effectiveness)
• Drafts, revises, reviews, and/or approves controlled documents including Standard Operating Procedures
• Represents QA on cross-functional project teams and with external partners
• Identifies and anticipates trends in quality issues; collaborates with leadership team to implement quality initiatives
• Responsible for managing CSV oversite including planning and scheduling validation activities with external vendors
• Ensures business partners assess and approve change controls for commercial processes for assessment of lot disposition processes
• Identifies areas of improvement in training system performance, training process and overall training procedures
• Manages training KPIs
• Ensures business partners implement adequate training modules and learning activities
• Contributes to the development, maintenance, and continuous improvement of SOPs, work instructions, and templates

Senior Manager, GMP and QMS

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

Senior Manager, GMP and QMS

Director, Medical Writing