Karyopharm Therapeutics Inc.

  • Senior Medical Writer

    Job Locations US-MA-Newton | US-NJ | US-NY | US-NC | US-PA | US-IL
    Job ID
    # of Openings
    Medical Affairs/HEOR
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.



    • Generate clinical study−related documents, including protocols, protocol amendments, Investigator Brochures, and clinical study reports to support Karyopharm clinical development programs
    • Lead cross-functional teams in order to author and review clinical documents
    • Contribute to the generation and maintenance of templates and standard text for clinical documents
    • Contribute to the generation and review of SOPs relating to Medical Writing processes
    • Provide document support as needed to Regulatory Affairs
    • Provide training and guidance to junior staff regarding Karyopharm Medical Writing best practices
    • Provide quality control review as necessary for clinical and regulatory documents, when needed
    • Working with the lead Medical Writer of a regulatory submission, contribute to the development of Module 2 summary documents



    • At least 5 years of Medical Writing experience with evidence of increasing responsibility/technical development (experience in clinical development may partially contribute to the 5 years of writing experience)
    • BS or equivalent degree in a scientific area. Advanced degree (MS, PhD, PharmD, or MD) preferred
    • Knowledge of ICH regulations relevant to medical writing
    • Demonstrated ability to work in collaboration with others and lead cross-functional team meetings
    • Ability to understand/interpret statistical outputs summarizing data collected during clinical trials
    • Experience in developing summary documents included in regulatory submissions (eg, NDA, BLA, MMA) is a plus
    • Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft Powerpoint and SharePoint
    • Ability to successfully multitask; working on multiple projects at the same time with 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



    This position is an onsite role, however, we will consider remote candidates located in the eastern part of the U.S. who are willing to be onsite on a monthly basis.



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