Regulatory Information Management Specialist

4 weeks ago

Los Angeles, United States Platinum Resource Group Full time
Job DescriptionJob Description

Regulatory Information Management Specialist needed for a 100% remote, 12+ month contract with our client. 

JOB DESCRIPTION

Responsible for supporting data entry/management of regulatory information, data quality/stewardship, document management and RIM processes. The incumbent will have a general working knowledge of Regulatory Affairs, Health Authority submissions and archives. This role offers an exciting opportunity to contribute to the advancement of treatments for individuals affected by rare diseases through effective management of regulatory data and support for related systems.

  • Executes Regulatory Information Data Quality procedures such as data monitoring and data cleansing.
  • Evaluation of data quality issues in Regulatory Systems (e.g., Veeva Vault RIM) through the review/analysis of system generated reports.
  • Support the development and maintenance of Regulatory Information Data standards.
  • Provides support to Business Administrator for Regulatory systems as needed.
  • Supports Regulatory System enhancements through contributions to impacted functional business processes.
  • Supports reporting and dashboarding of Regulatory Information as needed to meet business requirements.
  • Promotes a culture of quality, operational excellence, and continuous improvement, supporting company growth.

 

QUALIFICATIONS

  • Bachelor's degree within a life sciences subject or information technology.
  • 3+ years' experience in Regulatory, Regulatory Information Management, Regulatory Technology
  • Experience with document management and regulatory information tracking supporting Regulatory Affairs submissions and related activities.
  • Understanding and hands-on experience with technologies (e.g., SharePoint, Veeva Vault RIM, etc.) supporting the global Regulatory business.
  • Experience with Veeva Vault RIM required and experience with Veeva Vault RIM Submissions and Submissions Archive experience is highly desirable.
  • Experience providing user support and training in Regulatory Systems supporting Regulatory Information Management.
  • Detail-oriented with the ability to organize, prioritize, and execute required tasks to meet timelines.
  • Ability to work independently and use critical thinking to perform tasks with appropriate escalation to manager.
  • Highly collaborative team player with excellent communication and interpersonal skills enabling development of positive relationships.
  • Proficient in the use of Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio).
  • Experience with Smartsheet and SharePoint is a plus
Company DescriptionPlatinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, paid holidays, and referral bonuses.Company DescriptionPlatinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, paid holidays, and referral bonuses.

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