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Senior Associate, Regulatory Information Management

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

The Senior Associate, Regulatory Information Management (RIM), provides Global Regulatory Affairs support for Jazz's RIM system (JazzVault RIM). This position will work closely Global Regulatory Affairs, as well as other functions within R&D, and with IT, to support training, documentation, user experience, and maintenance of the RIM system and acts as a champion for the broader Global Regulatory team and its use of the RIM system.

Responsibilities:

  • Support for JazzVault RIM for users across R&D, working to leverage optimal value for Jazz from the Veeva Vault RIM suite of products
  • Develop training material regarding JazzVault RIM, and contribute to user communications including newsletters and intranet page for the system
  • Support requests from users across GRA, R&D contributing groups, and IT, ensuring information management needs are met and requests for information are handled in a timely fashion;
  • Support activities related to system maintenance, liaising with IT and the business on version releases;
  • Interfaces with system end-users to identify necessary ad hoc regulatory/compliance related system updates and resolves requests relevant to in-scope activities;
  • Work with IT and vendor (Veeva) to support Veeva Vault RIM system updates and releases;
  • In conjunction with IT, manage user accounts in JazzVault RIM including user permissions and security profiles;
  • Support Veeva Vault RIM configuration requests by working with IT, Veeva and functional GRA representatives;
  • Support IT in validation testing as needed;
  • Assist with SOPs, Manuals, or other training materials for Veeva Vault RIM and works collaboratively with QA and Regulatory Affairs teams.
  • Supports migrations requests and database entry.
  • 10% to 20% travel is required



Minimum Requirements

  • Bachelor's degree
  • Excellent communicator and team player who gets the job done - this is a hands-on position
  • 2 years of Regulatory Affairs experience required
  • Understanding of Regulatory activities, projects, and processes
  • Experience in Veeva Vault Regulatory Information Management software or equivalent preferred
  • A working knowledge of Pharmaceutical/Biotech Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
  • Ability to multitask effectively in a fast-paced environment with often shifting priorities
  • Ability to work independently with minimal supervision or direction
  • Excellent verbal and written communication skills
  • Experience document archiving


Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Senior Associate, Regulatory Information Management

Philadelphia, PA
Full Time

Published on 07/11/2020