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Job Description: Please note this role is 50% onsite (Hybrid). We have opened up flexibility such that candidates that can commute to the following sites will be considered.

Devens, MA
Cambridge, MA
Summit, NJ
Warren, NJ
New Brunswick, NJ
Lawrenceville, NJ
Princeton Pike, NJ
Nassau Park, NJ
Tampa, FL
Libertyville, IL

Job Title: RIM Contractor
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

Degree Requirements BS/BA in a relevant scientific or technical field preferred.
Additional experience may be considered in lieu of a degree

Experience Requirements
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.
Additional Sills: