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Regulatory Information Management (RIM) Consultant

Trenton, NJ 08648

Posted: 03/22/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 553390 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 35-50/hr **salary will be commensurate with experience 

Position Summary / Objective:

The RIM contractors is accountable to enter and manage RIM data. They create and monitor CMC change control for commercial and investigational product. Create submission content plan to feed in the DCN for CS portal maintenance as well as creating CMC information records to capture new submitted and approved CMC updates for all impacted fields in the RIM tool.

Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems. Monitor data quality, accuracy and integrity. Participate in system testing for upgrades by executing scripts and being involved in validation.

Position Responsibilities:
  • 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
  • May be asked to contribute to the resolution of corrective preventive action plans in defined area of expertise
  • At the request of management, prepares data in supports of meetings as they related to developed areas of expertise
  • Recognizes and reports data compliance issues, and is able to derive how they impact assigned processes and other processes
  • Executes operational aspects of assigned regulatory processes according to procedures

Experience Requirements:
  • Degree Requirements 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

Key Competency Requirements:
  • 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
  • Basic understanding of electronic records management rules
  • Participates in projects and communicates and interacts with internal customers
  • Practical experience with desktop application software suites
  • Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills.
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