Immunomedics, Inc.

  • Regulatory Operations Specialist- Electronic Publishing

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(1/2/2019 11:11 AM)
    Job ID
    2018-1385
    # of Openings
    1
    Category
    Regulatory
  • Overview

    The Regulatory Operations Specialist is Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time.  The position will also archive and track regulatory correspondences, documents and submissions.

    Responsibilities

    • Electronically format, publish electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
    • Manages submission timelines and content plans.
    • Provides guidance on good documentation and submission practices to project teams
    • Assists with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures
    • Identifies and communicates regulatory system enhancement needs or technical issues
    • Maintains Document Authoring Template Library and Template development

    Qualifications

    • Good understanding of applicable FDA and ICH guidelines related to regulatory submissions
    • Good understanding of eCTD publishing systems, EDMS technology (Veeva Vault preferred) and authoring tools and templates (StartingPoint preferred)
    • Clear understanding of regulatory submission content and format requirements
    • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
    • 2-5 Years

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