About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type:6 Month Contract
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $53.57– $55.14hr
Job Location: 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:
The RIM contractors are 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.

Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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INDOJ