Regulatory Information Management Specialist

Found in: Appcast US C2 - 2 weeks ago


Sacramento, United States Tandym Group Full time

Our client, a leader in the pharmaceutical industry, is seeking a Regulatory Information Management Specialist to join their team. This role will be responsible for supporting data entry/management of regulatory information, data quality/stewardship, document management and RIM processes.

**This job is remote - USA**
**W2 Only**

Responsibilities:

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


Qualifications:

  • Must haves: Veeva Vault RIM, Data quality monitoring, Document Management, Regulatory Information Tracking (Submissions, Questions, Commitments, etc), Works independently
  • Experience with document management and regulatory information tracking supporting Regulatory Affairs submissions and related activities.
  • Hands-on experience with technologies (e.g., SharePoint, Veeva Vault RIM, etc.) supporting the global Regulatory business.
  • Veeva Vault RIM Submissions & Submissions Archive experience, highly desirable.
  • Experience providing user support and training of 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, Power Point, Project, Visio).
  • Bachelor's degree (within a life sciences subject or information technology) with 3+ yrs experience in Regulatory, Regulatory Information Management, Regulatory technology or equivalent.


Desired Skills

  • Looking for someone more on the technology background, not in the business administration background
  • Knowledge of Regulatory Submissions and Archiving processes
  • SharePoint and Smartsheet experience


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