Immunomedics, Inc.

  • Senior Director, Regulatory Operations & Publishing

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(1 month ago)
    Job ID
    2018-1285
    # of Openings
    1
    Category
    Business Office
  • Overview

    Senior Director, Regulatory Operations and Publishing will establish appropriate internal system and vendor management of external operations depending on the level of need for project execution. Will work effectively with product development teams as a cross-functional R& D operations leader in all aspects of drug development, technology implementation and process as well as manage vendor alliance with external vendors as needed for other publishing activities. Will oversee the internal publishing and document management systems and be responsible for the implementation of Veeva vault regulatory. Will develop and manage a small internal group of publishers to support regulatory and clinical functions and development activities, responses to health authorities and regulatory submissions. This individual will help implement R& D operations planning strategies and organizational change management.

    Responsibilities

    Regulatory Operations & Publishing Senior Director will play a critical and leading role in establishing internal publishing and operations capabilities and be responsible for vendor and alliance management as well as service level agreements with any external publishing vendors as needed. Support the daily activities to deliver to Health authorities regulatory documentation in compliance with regulations.

    • Develops regulatory submission strategies to support implementation of Veeva vault Regulatory capabilities for e-publishing, document standards and records management for all regulatory correspondences.
    • Advises on the development and implementation of operations and systems optimization of technologies and platforms associated with R& D operations
    • Lead submission process team
    • Maintains current knowledge of regulations regarding submission requirements, and instructs the team of changes to process
    • Proactively identifies program issues and implements appropriate regulatory strategies to mitigate risks.
    • Strategic R& D Operations planning
    • Strong organizational and communication skill set
    • Proven track record of successful on-time submissions
    • Regulatory knowledge of submission requirements, content and format for submissions to Global health authorities
    • Publishing Management (Document dossier standards and e-Publishing)
    • R & D Records Management
    • Vendor and Alliance management
    • Knowledge and experience with electronic document management system (Veeva)

    Qualifications

    • BA in Science or related field with 10 to 15 years experience in Pharmaceutical Industry
    • All key internal functions, Regulatory, Clinical and Clinical Safety.

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