Immunomedics, Inc.

  • Medical Writer, Data Management

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(4/11/2018 11:37 AM)
    Job ID
    2018-1093
    # of Openings
    1
    Category
    Medical Affairs
  • Overview

    The Medical Writer works directly with the medical project team to develop scientifically valid and complete documents for regulatory submission, conferences and publications such as abbreviated or full clinical study reports, Investigator Brochures and other documents, as needed. The Medical Writer reports to the Head of Data Management.

     

    Please note that it is required that you must work on-site. This is NOT a remote position.

     

     

    Responsibilities

    • Summarizes data from Clinical studies
    • Writes and edits clinical study reports for regulatory agencies and other stakeholders in accordance with ICH guidelines, standard operating procedures and AMA writing styles, adhering to project timelines.
    • Initiates and maintains communications with relevant medical team members from other functional within and outside the Medical Department
    • Provides guidance on submission strategy, tactics and tools to insure the timely submission of high quality, critical documents.
    • Actively participates in project team meetings to provide input regarding deliverables, timelines and processes for the completion of documents
    • Assists in the development of project timelines, Standard Operating Procedures and guidance documents
    • Administrates as appropriate the receipt, collation and incorporation of review comments needed for completion of regulatory and other documents, as needed.
    • Develops a comprehensive understanding of study design, objectives, analyses plans, and results

    Qualifications

    • The ideal candidate will possess an advanced scientific degree (MS, PharmD or PhD).
    • 5 or more years of medical writing experience in the pharmaceutical or biotechnology industry or at a CRO including experience in the following areas of medical writing: clinical protocols, CSRs, IBs, clinical section of the IND, and BLA/NDA (ISS/ISE)
    • Experience with eCTD and electronic document management systems
    • Knowledge with ICH, GCP, and regulatory guidelines. 
    • Attention to detail – style, grammar, syntax, scientific accuracy
    • Ability to work professionally and proactively with diverse team members
    • Excellent verbal and written communication and the ability to write and edit complex material to ensure accuracy clarity and effectiveness
    • Understanding of the drug development process
    • Current knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of eCTD requirements with respect to structure, format and content
    • Strong PC Experience and demonstrated proficiency with the MS Office Suite applications, Adobe Acrobat, and electronic document management systems

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