Job Title: Sr. Manager, RIM Systems and Publishing
Department: Regulatory
Location: Remote
FLSA Status: Exempt
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.
- 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.
Education and Experience- 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.
Skills and Qualifications- 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.
Physical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
#LI-REMOTE
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Remote - United States - US: $149,860 - $181,595San Diego - CA - US: $164,846 - $199,754
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
