PRAHS

  • Principal Medical Writer

    Job Locations (All) | US-Remote
    Posted Date 3 days ago(11/11/2018 9:40 AM)
    ID
    2018-48214
  • Overview

    Primary Responsibilities

    • Writes and reviews scientific manuscripts, clinical study reports, regulatory submissions, and other clinical documents.
    • Leads project teams in drafting individual report specifications and in coordinating data analysis.
    • Contributes to clinical protocol development.
    • Consults with and advises other medical writers and clients in the development of clinical plan outlines.
    • Acts as a member of process improvement and interest groups.

    Responsibilities

    • Acts 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.
    • 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 inservice 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.
    • May manage direct reports, as needed

    Qualifications

    Primary Qualifications:

    • Demonstrates strong ability in developing pharmaceutical drugs for human use.
    • Shows substantial skill in writing technical sections of regulatory documents,clinical study reports, poster presentations, and manuscripts for publication in a scientific journal.
    • Fully understands regulatory submissions requirements and clinical study report guidelines in host country.
    • Exhibits excellent written and oral communication and presentation skills.


    Minimum 5 years of experience in regulatory medical writing

    Advanced degree (MS minimum) required; strong preference for doctoral degree (PhD, PharmD, MD)

    See above for required qualifications.

    Additional qualifications include experience with the following:

    • non-technical summaries for lay people
    • nonclinical writing
    • PIP/PSP
    • marketing submissions (NDA/BLA/MAA)



     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

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

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