Overall regulatory lead for the Fertility Equipment business unit and UK - based regulatory team. Responsible for compliance and regulatory strategies for various markets.
About the role
- Veeva Vault RIM Senior Specialist optimizing the Veeva RIM platform in pharmaceuticals. Leading technical implementation and providing expert guidance to RIM specialists.
Responsibilities
- Configure Vault objects, object types, lifecycles, workflows, role/permission models, document types, metadata and page layouts.
- Implement automation (entry actions, user actions, validation rules, workflow steps, object actions, permissions) to support a streamlined business process.
- Develop advanced reports and dashboards; optimize search, metadata, and taxonomy for regulatory use cases.
- Maintain configuration documentation (requirements traceability, design specs, configuration logs).
- Design integrations between Veeva Vault RIM and upstream/downstream systems.
- Experienced with Veeva Vault Loader.
- Implement data quality controls, reference data standards, and master data alignment (products, substances, organizations; IDMP/SPOR).
- Troubleshoot integration and data flow issues.
- Lead technical delivery for configuration changes and releases (sandbox build, migration to test/prod, deployment scripts, release notes).
- Support computer system validation (CSV) for GxP-relevant changes: (co-)author design and test plans, create test scripts, capture evidence, manage deviations, and support QA reviews in line with GAMP 5 and internal SOPs.
- Ensure audit-readiness: maintain configuration baselines, change control records, and technical documentation.
- Provide Tier 3 support for complex issues; perform root-cause analysis and corrective actions.
- Mentor and guide RIM analysts and junior configurators; review configurations for quality and compliance.
- Collaborate with business analysts to translate user requirements into technical designs; participate in UAT planning and defect triage.
- Work closely with the Platform Owner and Architect to align builds with standards and roadmap decisions.
- Coordinate with business and IT to ensure solutions meet business and compliance needs.
- Evaluate new Vault RIM features/releases and provide technical impact assessments and implementation plans.
Requirements
- 5-7+ years in Veeva Vault RIM technical configuration and development, including hands-on experience across core modules (Registrations, Submissions, Submissions Archive)
- Expert-level configuration skills: lifecycles, workflows, permissions, automation, document/object model, metadata, reports/dashboards
- Proven experience delivering integrations via Vault REST APIs, Web Services, middleware (Boomi/MuleSoft), and secure file transfer; strong understanding of data mapping and error handling
- Strong grasp of regulatory processes for pharmaceuticals and biologics and related data structures (global submissions, variations, renewals, IDMP)
- Demonstrated competence in CSV for GxP systems: test design, execution, evidence management, and change control
- Excellent troubleshooting, documentation, and communication skills; ability to mentor others and review technical work
- Bachelor’s degree in Computer Science, Information Systems, or Life Sciences (or equivalent experience)
Benefits
- Exciting work in a great team, global projects, international environment
- Opportunity to learn and grow professionally within the company globally
- Hybrid working model, flexible role pattern (e.g., even 80% full-time is possible in justified cases)
- Pension and health insurance contributions
- Internal reward system plus referral programme
- 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
- Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card
- Vodafone, Raiffeisen Bank and Foodora discount programmes
- Up-to-date laptop and iPhone
- Parking in the garage, showers, refreshments, massage chairs, library, music corner
- Competitive salary, incentive pay, and many more
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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