Regulatory Information Management
3551 Lawrenceville Road Trenton, NJ 08648 US
Target Pay Rate: 40-53.57/hr **salary will be commensurate with experience
Functional Area Description Global Regulatory Business Capabilities
- In collaboration with the business, sets the strategic business direction for the development and maintenance of systems used in GRS, including responding to any needs for regulatory data from other parts of the enterprise
- Oversees strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systems
- Establishes and maintains a set of regulatory standards for data and processes in scope
- Evaluates internal and external requirements and guidances with impact to compliance and processes, especially where systems are impacted
Position Summary / Objective:
The RIM Labeling Consultant is accountable to enter and manage regulatory information (RIM) associated with global labeling.
Distribute notification of regulatory changes to country regulatory managers for their assessment against the current local label and submission planning. Monitor data quality, accuracy and integrity, ensure country-level data is available in a complete, and timely manner
Run reports to identify issues and analyze data trends. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems.
- Maintains good understanding of the assigned regulatory processes with specific areas of expertise
- Manages daily workload and independently addresses questions for assigned regulatory processes
- Contributes to and helps identify system and process gaps in developed areas of expertise which includes update to User Guides, Quick Reference Guides and reports for analysis.
- At the request of management, prepares data in support of meetings as they relate to developed areas of expertise
- Recognizes and reports data compliance issues, and can derive how they impact assigned processes and other processes
- Executes operational tasks for regulatory processes according to RIM procedures and work instructions.
BS/BA in a relevant scientific or technical field preferred. Additional experience may be considered in lieu of a degree.
- Minimum of 3 years of relevant experience
- Demonstrates critical thinking skills and the ability to apply this to daily workload decisions
- Demonstrates awareness of the procedures and decision-making process of relevant Health Authorities.
- Strong understanding of regulatory operations
- Knowledge of computer systems in an R&D environment. Knowledge of Veeva RIM & Vault systems a plus
- Proficiency in Excel functions, Pivot Tables and reports
- Basic understanding of electronic records management rules
- Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.