PRAHS

  • Principal Medical Writer

    Job Locations - | US-Remote
    Posted Date 6 days ago(4/20/2018 11:45 AM)
    ID
    2018-45044
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

    We are 15,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting lifesaving drugs into the hands those who need them most.

     

    Who are you?

    You are a Medical Writer who researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge. 

     

     
     

    Responsibilities

    What will you be doing?

    • Act as a lead medical writer on numerous programs and individual studies at a moderate to complex level.
    • Provides scientific and medical writing consultancy to clients and internal colleagues at a complex level.
    • Leads project teams in drafting report specifications, medical writing, and coordination of regulatory submissions and data analysis.
    • Manages all aspects of the medical writing function, including line management. 
    • Serves as an active mentor to all levels of medical writing personnel. 
    • Develops and implements training for medical writers.
    • Oversees operational activities of other medical writers as the project team leader.
    • Conducts in-service training for clinical research associates, other clinical functions, and clients in areas of therapeutic expertise. 
    • Provides bid estimates for medical writing work for potential projects and attends bid defense meetings when requested.

     

    Qualifications

    What do you need to have?

    • 10 years of experience in science or medical-related writing with emphasis on regulatory submission document writing 
    • PREFERRED - Master’s degree in a science or health-related field
    • Submission/module 2 document experience is 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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