This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

The Director, Medical Writing will take lead in preparation of different types of clinical and regulatory documents and will oversee the writing of clinical documentation in support of clinical development (e.g., protocols, IBs, CSRs, etc.) and regulatory filings (e.g., clinical modules in IND and NDA). They will mentor other medical writers, drive key operational workstreams, ensure all documents adhere to established program strategy, and provide key recommendations for improved outcomes.

• 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 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.
• Work with the Head of Medical Writing to develop medical writing processes, standards, and innovative initiatives.
• Work in a collaborative manner with team members from various functional groups.
• 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.
• Significantly contribute to discussions regarding document content, informed by review of pertinent publications, guidance and/or discussions with outside experts.

Qualifications

• 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.
• Demonstrated abilities in collaboration with others and independent thought.
• 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 and the potential to receive annual target bonuses.
• Base salary range for this position is $200 K – $220 K USD.
• Peace of mind through best in class medical, dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend.
• Generous PTO and Holidays.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, patient-focused company.
• Cell phone allowance.