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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Regulatory Information Management (RIM) Consultant

Job Description

  • Location: Princeton, NJ
  • Type: Contract
  • Job #75499

Our client, a leading pharmaceutical company, is hiring a Regulatory Information Management (RIM) consultant on a contract basis.

Work Location

The position is fully remote, as our organizations contractors are not allowed to come on site due to space constraints.

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.

Pay Range:  $50-53

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