Senior Manager, RIM Systems and Publishing

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🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $149.9k - $181.6k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 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 leads 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