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Job

Associate - Senior Associate, Regulatory Systems Support

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Samuel Cantillo

  • Contact email:

    s.cantillo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-10-24

  • Startdate:

    ASAP

Associate - Senior Associate, Regulatory Systems Support

Hybrid, 3 days in office

Location: New Jersey

Responsibilities

  • Training employees on using regulatory systems.
  • Going through UAT testing; Initiating UAT Scripts, deployment of software.
  • Troubleshooting issues for regulatory employees on systems for users with issues.
  • Running reports for data integrity for the systems (SOP validation, naming conventions adhered to).
  • Support and manage Regulatory Information Systems according to business needs and regulatory compliance.
  • Optimize system enhancements to their operational capabilities according to business needs.
  • Create and develop user requirements specifications and business justifications for future information systems.
  • Engage with vendors and internal partners to drive future state of-the shelf software packages.
  • VEEVA - RM Vault; Edge; TRS Viewer

Requirements

  • BS/BA  in computer science or related field with 3 years of experience in Document Management Systems.
  • Experience supporting regulatory information in Regulatory Information Management systems or experience with systems publishing tool.
  • Pharmaceutical industry experience is an advantage.
  • Experience mapping User Requirements to Functional Specifications in respect of process management is an advantage.

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