Senior Manager, RIM Systems and Publishing

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🕒 vor 1 Tag

🏄 California – Remote

🏄 California – Remote

💵 $149.860 - $181.595 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Bristol Myers Squibb

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1887

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Bristol Myers Squibb ist ein globales Biopharmaunternehmen, das sich der Entdeckung, Entwicklung und Bereitstellung innovativer Medikamente widmet, die Patienten helfen, schwere Krankheiten zu überwinden. Die Schwerpunkte liegen in den Bereichen Herz-Kreislauf-Gesundheit, Zelltherapie, Immunologie und Onkologie. Mit dem Ziel, die Behandlungsergebnisse der Patienten durch bahnbrechende Wissenschaft zu verbessern, arbeitet Bristol Myers Squibb mit einem weltweiten Netzwerk von Forschern, Gesundheitsdienstleistern und anderen Interessengruppen zusammen. Das Unternehmen strebt danach, führend in der patientenorientierten Innovation zu sein und setzt sich gleichzeitig für Vielfalt und Inklusion innerhalb der Belegschaft ein.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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