Regulatory Information Management Specialist
2 weeks ago
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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