Position Summary / ObjectiveThe RIM Labeling Contractor is accountable to enter and manage regulatory information in the authoritative system. Specifically this individual will enter global labeling revisions of the Company Core Data Sheets (CCDS) for commercial products. Notifications of these regulatory changes are sent via a RIM workflow to country regulatory managers who assess it against the current local label and plan submissions. The RIM contractor will monitor data quality, accuracy, and ensure country-level data is available in a complete, and timely manner. Create reports/metrics to identify issues and analyze data trends. Function as a strong RIM user, interact with country regulatory associates, address questions and solve problems. Utilizing training on other regulatory processes, this associate will also support ad-hoc RIM requests. Participate in system testing for upgrades by executing scripts and being involved in validation.
• Functions as a process expert for labeling submissions and CCDS updates in the RIM system.
• As a detail-oriented worker, manage daily workload independently understanding the business goals.
• Runs data quality reports to check process compliance on local assessments. Inform country managers of issues. Arrange meetings as needed to advise them on use of
the system and resolve the problems.
• Update data quality trackers and escalate issues when necessary.
• Use Excel to summarize information for inclusion in Power Point presentations provided to management.
• Contributes to and helps identify system and process gaps in labeling. Develop new RIM reports and dashboards.
• Provides support for internal audits, HA inspections and may be asked to contribute to the resolution of corrective preventive action plans.
• Executes operational tasks according to RIM procedures and work instructions.
Degree Requirements - BS/BA in a relevant scientific or technical field preferred
• Minimum of 3 – 5 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 government Health Authorities and how it relates to RIM
• Strong understanding of regulatory operations
• Knowledge of computer systems in an R&D environment. Firm knowledge and experience with eCTD, SPL and submission standards. Ability to navigate marketing application submissions structure and content. Basic understanding of electronic records management rules
• Participates in projects and communicates and interacts with internal and external 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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Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
Phone: (212) 488-7460
Fax : (212) 306-0191