PRAHS

  • Sr Medical Writer

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(11/30/2018 9:00 AM)
    ID
    2018-50464
  • Overview

    Applies a wide range of therapeutic expertise and clinical drug development knowledge to the development of drugs, biologics, devices and/or other products for human use in developing individual clinical study protocols, clinical plan outlines, drug development programs, clinical study reports, manuscripts, investigator brochures, and sections of regulatory submission documents. Also provides therapeutic training to external clients and internal PRA staff.

    Responsibilities

    • Acts as a Lead medical writer on numerous programs or on numerous individual studies at a simple to complex level.
    • Acts as Lead medical writer on submissions projects of a simple to complex level.
    • Represent client at regulatory agency meetings in association with projects, if required.
    • A technical expert in their field and presents at scientific conferences.
    • Develops a network of clients and may provide new leads for Business Development opportunities.

    Qualifications

    • Substantial experience in pharmaceutical or CRO industry developing pharmaceutical drugs for human use required e.g. non-clinical science, medical related writing, protocol writing, writing for regulatory submissions, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials
    • Substantial experience writing clinical study reports, other regulatory submission documents, poster presentations, and manuscripts for publication in a scientific journal required
    • Experience using computerized systems (PC-Windows, and MS Office) required
    • Knowledge of regulatory agency requirements for protocols and regulatory submissions in the host country required
    • Direct or indirect experience interacting with FDA or host country regulatory agency required
    • Demonstrated project leadership skills required
    • Read, write and speak English; fluent in host country language required



    • An advanced degree (M.S., PharmD, PhD., M.D.) or its international equivalent in a health science from an accredited institution



    • PhD. preferred





    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

     

     To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.







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