Karyopharm Therapeutics Inc.

  • Senior Medical Writer

    Job Locations US-MA-Newton
    Job ID
    2018-1075
    # of Openings
    1
    Category
    Medical Affairs/HEOR
    Type
    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.

     

    Responsibilities

    • 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, draft sections of summary documents.

     

    Qualifications

    • 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 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 Please Review software
    • 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

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