Manager, RIM Governance and Engagement
Core
Manage Regulatory Information Management (RIM) system governance, data quality, and global regulatory event workflows to ensure compliance and documentation of regulatory approvals.
Role type
Manager, Regulatory Information Management (RIM) Governance
Builds
Global regulatory event workflows, data quality reports, and compliance documentation within the RIM system
Domain
Life Sciences / Regulatory Affairs / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
RIM system administration, regulatory event creation and tracking, data quality analysis, workflow management, cross-functional collaboration, issue resolution
Preferred skills
Experience with health authority correspondence, CMC change controls, labeling change controls, investigator brochure management
Technologies
RIM system, workflow automation tools
Responsibilities
Upload health authority correspondence and create queries in RIM; Create and track global CMC Change Controls, IMP Amendment events, and Labeling Change Control events; Perform data quality checks on Labeling Events and drive reporting; Create Investigator Brochure and Marketing/Investigational registration events; Troubleshoot system issues and provide user support to local markets
Seniority
Manager, hands-on IC