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Senior Manager, RIM Systems and Publishing
Job Description:
- Serve as business administrator and business owner for Veeva Vault RIM platforms, including Submissions, Submissions Archive, and Publishing
- Lead Veeva Vault RIM governance, optimization, end-user support, and continuous improvement of Regulatory Operations processes
- Maintain and govern RIM master data, metadata standards, controlled vocabularies, relationships, and business rules
- Lead Vault Publishing administration and assist with validation and implementation
- Support submission le with content plans, publishing configuration, workflows, publishing rules, validation, troubleshooting, and submission readiness
- Develop and deliver system training, SOPs, work instructions, job aids, process flows, and governance documentation
- Partner with IT and Quality on release management, system validation, change control, user access management, and compliance requirements
- Develop and maintain system metrics, dashboards, and reports for operational oversight, compliance monitoring, data quality, and leadership decision-making
- Maintain current knowledge of Veeva Vault RIM functionality, regulatory submission requirements, electronic publishing standards, and industry best practices
- Perform or support submission publishing activities as needed
Requirements:
- Bachelor's degree with 8+ years of relevant experience in regulatory systems or regulatory operations
- Hands-on experience administering and supporting Veeva Vault RIM applications, including Submissions, Submissions Archive, and Publishing
- Experience with eCTD publishing solutions and regulatory submission workflows
- Experience supporting Veeva RIM Publishing implementation preferred
- Strong understanding of regulatory submission processes, eCTD structure, publishing requirements, and submission lifecycle management
- Strong understanding of data governance, metadata management, document classification, and inspection readiness principles
- Ability to translate business requirements into practical system processes and governance standards
- Strong troubleshooting skills for complex system, publishing, and process issues
- Ability to train and support end users with varying levels of system experience
- Ability to manage system initiatives, governance activities, user support, and operational priorities
- Ability to collaborate with Regulatory Affairs, IT, Quality, vendors, and cross-functional business users
- Proactive, professional, and confident
- Excellent professional ethics and integrity
Benefits:
- Medical, pharmacy, dental, and vision care
- BMS Well-Being Account
- BMS Living Life Better
- Employee Assistance Programs (EAP)
- 401(k) plan
- Short- and long-term disability insurance
- Life insurance
- Accident insurance
- Supplemental health insurance
- Business travel protection
- Personal liability protection
- Identity theft benefit
- Legal support
- Survivor support
- Flexible time off for US exempt employees, with manager approval
- 11 paid national holidays
- 160 hours annual paid vacation for eligible new hires
- 3 optional holidays for eligible employees
- Unlimited paid sick time, based on eligibility
- Up to 2 paid volunteer days per year
- Summer hours flexibility, based on eligibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Year's Day
- Additional incentive cash and stock opportunities, based on eligibility
- Reasonable workplace accommodations/adjustments and ongoing support