Senior Manager, RIM Systems and Publishing

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the business administrator and owner for Veeva Vault RIM platforms, encompassing Submissions, Submissions Archive, and Publishing.

• Spearhead Veeva Vault RIM governance, process optimization, end-user assistance, and the ongoing enhancement of Regulatory Operations workflows.

• Oversee and regulate RIM master data, metadata standards, controlled vocabularies, interrelationships, and business rules.

• Manage Vault Publishing administration and provide support during validation and implementation phases.

• Assist submission leads in developing content plans, configuring publishing settings, managing workflows, establishing publishing guidelines, validating submissions, troubleshooting issues, and ensuring submission readiness.

• Create and present system training materials, SOPs, work instructions, job aids, process diagrams, and governance documentation.

• Collaborate with IT and Quality departments on release management, system validation, change control, user access management, and compliance obligations.

• Generate and sustain system metrics, dashboards, and reports for operational oversight, compliance tracking, data integrity, and leadership decision-making.

• Stay updated on Veeva Vault RIM functionalities, regulatory submission requirements, electronic publishing standards, and industry best practices.

• Execute or assist with submission publishing activities as necessary.

⛳️ Requirements

• Bachelor's degree with over 8 years of relevant experience in regulatory systems or operations.

• Practical experience in administering and supporting Veeva Vault RIM applications, including Submissions, Submissions Archive, and Publishing.

• Familiarity with eCTD publishing solutions and regulatory submission workflows.

• Experience in supporting Veeva RIM Publishing implementation is preferred.

• In-depth understanding of regulatory submission processes, eCTD structures, publishing requirements, and submission lifecycle management.

• Strong grasp of data governance, metadata management, document classification, and principles of inspection readiness.

• Ability to convert business requirements into effective system processes and governance standards.

• Excellent troubleshooting capabilities for intricate system, publishing, and process-related issues.

• Proficiency in training and assisting end users with various levels of system experience.

• Competence in managing system initiatives, governance activities, user support, and operational priorities.

• Ability to work collaboratively with Regulatory Affairs, IT, Quality, vendors, and cross-functional business users.

• Proactive, professional demeanor with a high level of confidence.

• Strong professional ethics and integrity.

🏝️ Benefits

• Comprehensive medical, pharmacy, dental, and vision care.

• BMS Well-Being Account.

• BMS Living Life Better program.

• Employee Assistance Programs (EAP).

• 401(k) retirement plan.

• Short- and long-term disability insurance.

• Life insurance coverage.

• Accident insurance benefits.

• Supplemental health insurance options.

• Business travel protection.

• Personal liability protection.

• Identity theft protection services.

• Legal assistance.

• Survivor support services.

• Flexible time off for US exempt employees, subject to manager approval.

• 11 paid national holidays.

• 160 hours of annual paid vacation for eligible new hires.

• 3 optional holidays for qualified employees.

• Unlimited paid sick leave, dependent on eligibility.

• Up to 2 paid volunteer days per year.

• Flexible summer hours, based on eligibility criteria.

• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military reasons.

• Annual Global Shutdown between Christmas and New Year's Day.

• Additional cash and stock incentives based on eligibility.

• Reasonable workplace accommodations and ongoing support.