Sr. Manager, RIM Systems and Publishing

Bristol Myers Squibb•San Diego, CA

6d•Remote

About The Position

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

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.
Highly organized, with the ability to manage system initiatives, governance activities, user support, and operational priorities.
Ability to collaborate effectively with Regulatory Affairs, IT, Quality, vendors, and cross-functional business users.
Proactive, professional, and confident.
Excellent professional ethics and integrity.

Nice To Haves

Experience supporting Veeva RIM Publishing implementation preferred.

Responsibilities

Serve as a business administrator and business owner for Veeva Vault RIM platforms (Submissions, Submissions Archive, and Publishing).
Lead Veeva Vault RIM governance, optimization, end-user support, and continuous improvement of Regulatory Operations processes through effective use of Veeva Vault RIM.
Maintain and govern RIM master data, metadata standards, controlled vocabularies, relationships, and business rules to ensure data integrity, consistency, traceability, reporting accuracy, publishing readiness, and inspection readiness.
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, as applicable, to support release management, system validation, change control, user access management, and compliance requirements.
Develop and maintain system metrics, dashboards, and reports to support 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 and/or support submission publishing activities as needed to support business priorities and resource demands.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval)
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or RayzeBio employees)
160 hours annual paid vacation for new hires with manager approval
11 national holidays, and 3 optional holidays
Unlimited paid sick time
Up to 2 paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day.