Bristol Myers Squibb
Website:
bms.com
Job details:
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 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.
Qualifications
- BA/BS degree, science / technology field preferred
- 4-6 years pharmaceutical experience; 2+ year of regulatory operations
Experience
- Strong knowledge of global regulatory practices and regulatory operations
- Strong knowledge of regulatory information management and submission guidelines and requirements
- Strong knowledge of various types of health authority interactions, including HA correspondence, HA queries and HA commitments
- Subject 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 solution
- Effective written and verbal communication skills
- Ability to prioritize and strong attention to detail
- Strong experience instructing/ training end-users
- Strong 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 doesn’t 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.
Supporting People With Disabilities
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.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1606825 Manager, RIM Governance and Engagement
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