Specialist, RIM Governance and Engagement

Job Description

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. The RIM Specialist will be responsible for planning, tracking, and monitoring regulatory activities and data compliance in the BMS Regulatory Information Management system. The Specialist will work regularly with internal BMS teams to ensure that data in the RIM tool is entered in a complete, accurate, and timely manner. 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 labeling 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 With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: