Senior IT Specialist, Regulatory Systems (Veeva RIM) | Remote
RemoteMexico
Job Summary
Own and manage Regulatory applications ensuring they are designed, operated, and maintained per business requirements. Serve as the functional business analyst gathering needs, defining requirements, and architecting solutions for Veeva, TrackWise, and LabVantage LIMS. Lead system validation, testing execution, and change management while overseeing maintenance, upgrades, and defect resolution. Act as the primary liaison between IT, business process owners, and external vendors to support global Quality and Regulatory IT projects. This remote position requires a Bachelor's degree, 3+ years of experience in IT business analysis or validation within Life Sciences, and mandatory Spanish and English skills.
Required Qualifications
- Bachelor's degree in Computer Science, Information Systems, or a related field
- 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry
- Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications
- Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance
- Ability to develop and execute test scripts, validation plans, and system documentation
- Technical knowledge of SQL, system integrations, and application configuration
- Spanish and English speaking and written communication skills are mandatory
- Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks
- Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance
- Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders
- Ability to translate technical concepts into actionable insights for non-technical teams
- Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits
- Basic understanding of Java, .NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries
- Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment
- Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts
- Familiarity with SaaS environments (e.g., Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions
- Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital
- Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc. regulatory authorities, global registration of products
Desired Qualifications
- Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments
- Basic project management experience (Agile, Waterfall, or hybrid methodologies)
- Strong problem-solving and analytical skills to address complex system issues
- Excellent communication and stakeholder management skills
- Basic project management skills to coordinate system upgrades (e.g., Veeva's 3 annual releases), implementations, or process improvements
- Familiarity with methodologies like Agile or Waterfall, often used in IT projects
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