Manager, RIM Governance and Engagement

Responsibilities

• Upload health authority correspondence into BMS s RIM system including the required metadata.
• Create Health Authority queries in RIM and track to closure. Ensures the correct keywords and submission/ correspondence linkages are established in RIM.
• Create Commitment records in RIM and send workflows/reminders to users on a regular basis. Responsible for contacting users when data quality findings are identified and ensures issues are corrected.
• Create and distribute global CMC Change Controls and IMP Amendment events for commercial and investigational products. Issue workflows in RIM to request assessments and submission planning. Send reminders, as needed, and track the events to closure.
• Create and distribute global Labeling Change Control events. Issue workflows to request assessments and submission planning. Send reminders, as needed, and track the events to closure.
• Perform data quality checks on Labeling Events which drive reporting to the BMS Labeling Office. Send routine reminders to local markets to correct labelling data quality findings identified through RIM reports. Summarize and track issues.
• Create Investigator Brochure events in RIM and close out events as requested.
• Create Marketing and Investigational registrations and update as needed, based on information gathered through RIM reports.
• Work autonomously with local markets to troubleshoot and resolve issues. Provide user support and address questions as needed.
• Prompt attention to business-critical activities to ensure compliance and appropriate documentation of regulatory approvals.