RIM Labeling Consultant
Category: Scientific & Clinical
Job ID: 302033
Date Posted: 05/30/2023
Title: Regulatory Information Management (RIM) Labeling Consultant
Location: Lawrenceville, NJ
Start date: ASAP
Our client is looking for the following:
- 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 company’s 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 guidance’s with impact to company's compliance and processes, especially where systems are impacted.
- 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.
With the following credentials:
- 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
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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