• Principal Clinical Regulatory Medical Writer

    Job Locations US-IL-Chicago
    ID
    2019-1087
    Category
    Regulatory
    Type
    Full-Time
  • Overview

    The Principal Clinical Regulatory Medical Writer is responsible for researching, writing, and editing clinical documents and summarizing data from clinical studies for submission to regulatory authorities and/or for publication or presentation.

    Responsibilities

    • Responsible for writing, formatting, and managing clinical regulatory documents including but not limited to Investigator Brochures, Clinical Study Reports, IND applications, Briefing Packages, and CTD Clinical summary documents.
    • Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
    • Ensure adherence to GCP, ICH guidelines, SOPs, and internal templates.
    • Closely interacts with statistics and programming departments, including participation in the development of statistical analysis plans and design of statistical outputs.
    • Organizes, conducts, and leads document development meetings and other meetings as necessary.
    • Manages processes and provides content guidance for contract medical writing support on an individual project basis.
    • Contributes to the development of formats and guidelines for clinical documentation.
    • Supports team timelines and goals as outlined by the Medical Writing Team Lead.
    • Remains informed of the latest professional, technological, and regulatory developments in medical writing and in relevant therapeutic areas.
    • Participates in study team and strategy meetings.
    • May periodically interact with various levels of management and CROs.
    • May assist in the development of publications (abstracts, posters, manuscripts, etc.).

    Qualifications

    • Five (5) to ten (10) years of clinical regulatory medical writing experience (pharmaceutical/biotech company or CRO) required
    • Has acted as the lead writer on more than 5 projects for at least 3 of the following deliverables: Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, INDs, NDAs required
    • Degree in life sciences or related field is preferred
    • Excellent verbal and written communication skills and an ability to lead discussions and resolve issues related to document development
    • Mastery of Good Documentation Practices required
    • Attention to detail and ability to generate clean, consistent, coherent documents
    • Solid understanding of the drug development process, clinical study conduct and data collection, and interactions essential for the production of regulatory submissions
    • Familiarity with all phases of clinical research and ability to learn new medical concepts quickly
    • Position may require evening and weekend work, as necessary to fulfill obligations.

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