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Medical Writer

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: November 22, 2021

Job Description:

Overseen by a more senior staff member, the Medical Writer will liaise with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion. The Medical Writer will be expected to resolve issues and escalate problems, as necessary. The individual in this position will write CSRs, CSPs, CSP amendments, narratives, IBs and IB updates in a variety of therapeutic areas. Training on Clinical Summaries and other regulatory documents may be provided.JOB RESPONSIBILITIES:

  • Working with the clinical teams, the Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Narratives, Investigator's Brochures. The work will be overseen (reviewed and edited, as necessary) by a more senior staff member, however, the Medical Writer is expected to drive the project, track deliverables, and ensure timely completion.
  • Liaises with study director and/or medical monitors to shape and review content of documents. Follows up with other functional groups for materials needed for document completion.
  • Tracks writing projects, and ensures adherence to regulatory guidelines and department document standards.
  • Ensures maintenance of document standardization through use of model documents/templates and appropriate peer review.
    • Updates job knowledge by tracking changes in writing guidelines; participates in educational opportunities, reads professional publications and maintains personal networks.Education
      • Bachelor's degree (advanced degree preferred)Experience
        • Minimum of 1+ years of industry experience
        • Working knowledge of the clinical research process and regulations/guidelines required. Scientific and technical reading, writing and editing skills required.
        • Strong organizational, interpersonal and written communication skills. Must be able to communicate effectively in large or small group settings. Effective influence and relationship management skills required.
        • Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.
        • Have strong organizational, interpersonal and communication skills, and be able to develop and present varied and unique ideas
        • Expected to have a good working knowledge of MS WORD, Adobe Acrobat, and use of one or more EDM systems.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Medical Writer, Healthcare , Basking Ridge, New Jersey

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