Consultant on a contract basis.
Work Location
50% onsite (Hybrid)
Devens, MA
Cambridge, MA
Summit, NJ
Warren, NJ
New Brunswick, NJ
Lawrenceville, NJ
Princeton Pike, NJ
Nassau Park, NJ
Tampa, FL
Libertyville, IL
Summary:
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
Title is RIM Labeling Consultant
Functional Area Description
Global Regulatory Business Capabilities
• 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 client 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 guidances with impact to client compliance and processes, especially where systems are impacted
Position Summary / Objective
The RIM Labeling Consultant is accountable to enter and manage regulatory information (RIM) associated with global labeling.
Distribute notification of regulatory changes to country regulatory managers for their assessment against the current local label and submission planning.
Monitor data quality, accuracy and integrity, ensure country-level data is available in a complete, and timely manner
Run reports to identify issues and analyze data trends. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems.
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 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.
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. 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