Karyopharm Therapeutics Inc.

Discovers, develops and commercializes novel, life-changing cancer therapies in disease areas with high unmet need.

Director, Medical Writing

Content WriterContent WriterFull TimeRemoteTeam 201-500Since 2008H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

33 days ago

Salary

$200K - $220K / year

Bachelor Degree7 yrs expEnglish

Job Description

• 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

Job 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

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