Senior Manager, RIM Systems and Publishing

🕒 August 5

🏄 California – Remote

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💵 $149.9k - $181.6k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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👻 Ghost score 23%

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Logo of Bristol Myers Squibb

Bristol Myers Squibb

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 plan development, publishing configuration, workflows, publishing rules, validation, troubleshooting, and submission readiness activities • 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 • 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

• Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life, and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees • 11 paid company holidays each year • Paid vacation for eligible employees • 3 optional holidays for eligible employees • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year, depending on eligibility • Summer hours flexibility • Medical, personal, parental, caregiver, bereavement, and military leaves of absence • Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees • Additional discretionary incentive cash • Stock opportunities

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