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    Senior Manager, Regulatory Information Management - Philadelphia, United States - Jazz Pharmaceuticals

    Jazz Pharmaceuticals
    Jazz Pharmaceuticals Philadelphia, United States

    3 weeks ago

    Default job background
    Full time
    Description

    Brief Description:

    The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz

    Essential Functions

  • Understand the business processes (across R&D and Manufacturing), regulatory and reporting requirements and converting these into RIM configuration ideas/proposals
  • Configure RIM (Sandbox, Validation, and Production environments) as per the agreed proposals
  • Working with other Business and System Leads across Jazz to ensure alignment of data, system configurations and user experience
  • User requirement gathering and creation of end user reports
  • Triage support requests from users across GRA and Manufacturing
  • Develop and deliver data and document migration strategies
  • Manage RIM user accounts (in conjunction with IT), including user permissions and security profiles
  • Creation and delivery of RIM training material specific to different levels of knowledge and experience of individuals across R&D and Manufacturing
  • Knowledge of other systems outside of RIM ., Publishing

    • Required Knowledge, Skills, and Abilities

  • Education with a minimum of 5 years of pharmaceutical/Regulatory Affairs experience
  • Veeva White Belt certified
  • Knowledge of US/EU/International Regulatory Requirements
  • Ability to manage timely delivery of projects and / or programs
  • Exceptional written and verbal communication skills

    • Required/Preferred Education and Licenses

  • Bachelor's Degree in Business or Life sciences is required
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