Veeva Vault Regulatory Information Management Senior Specialist

Job Description

The Position

We are looking for Veeva Vault RIM (Regulatory Information Management) expert to lead the configuration development and optimization of our Veeva Regulatory Information Management (RIM) platform to support pharmaceutical and biological Development. This role will lead the further technical implementation of the RIM roadmap translate business needs into scalable solutions and provide guidance to other specialists.

The ideal candidate will be responsible for building Vault configurations automations and designing integrations; executing releases and validation; and providing technical guidance to other RIM specialists. The candidate should bring deep Veeva Vault RIM technical expertise and strong working knowledge of regulatory processes to translate business requirements into robust compliant solutions.

What will you do

• 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.

Qualifications Skills & Experience Required

• 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
• Bachelors degree in Computer Science Information Systems or Life Sciences (or equivalent experience)

Nice to have

• Experience with Veeva Vault eTMF/Clinical
• Veeva Vault Administrator and RIM certifications
• Experience in medium-to-large pharma/biotech environments with multinational regulatory operations
• Familiarity with labeling workflows CMC data flows and connections to Quality Safety and Clinical systems
• Experience with data governance controlled vocabularies and reference data frameworks (IDMP/SPOR)

What we offer

• 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

Ready to take up the challenge Apply now!
Know anybody who might be interested Refer this job!

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.