Manager, RIM Governance and Engagement

At Bristol Myers Squibb, our employees often ask, Who are you working for a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Upload health authority correspondence into BMSs 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.

Qualifications:

BA/BS degree, science / technology field preferred4-6 years pharmaceutical experience; 2+ year of regulatory operations experience

Strong knowledge of global regulatory practices and regulatory operationsStrong knowledge of regulatory information management and submission guidelines and requirementsStrong knowledge of various types of health authority interactions, including HA correspondence, HA queries and HA commitmentsSubject matter expertise and strong knowledge in regulatory information management software and computer systems (Microsoft Office, Outlook, eCTD viewers and web-based applications) and technically skilled with such systems.Communicates questions and issues as they arise with possible solutionEffective written and verbal communication skillsAbility to prioritize and strong attention to detailStrong experience instructing/ training end-usersStrong experience in the development of work instructions and quick reference guides.Communication and change management skills

We hire for skills and capabilities, not just credentials if this role excites you, but doesnt perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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