• Boston, MA
    10 days ago

    Job Description

    The Veeva RIM Consultant is responsible for supporting and optimizing Veeva Regulatory Information Management (RIM) solutions within a regulated pharmaceutical or biotechnology environment. This role focuses on regulatory data remediation, system configuration, reporting, process improvements, and integration activities while ensuring compliance with global regulatory requirements. The consultant collaborates with Regulatory Affairs, Quality, IT, and business stakeholders to enhance Veeva RIM capabilities, support digital transformation initiatives, and improve regulatory operations through automation and data integrity.

    • DMP & PMS Experience is must
    • Looking for someone with technical experience with Veeva RIM
    • This person will be remediating data
    • Great to have, IDMP, eCTD, Veeva capabilities & SDLC
    • Experience with AI & the automation process space
    • Experience with integration between Veeva quality to Veeva RIM
    • Understands Veeva RIM reporting & KPIs
    • This person will be spending 65-70% of their time in Veeva RIM
    • Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Computer Science, Information Technology, Engineering, or a related discipline.
    • Configure, support, and optimize Veeva RIM modules to meet regulatory business requirements.
    • Perform regulatory data remediation, data migration, and data quality improvement activities.
    • Support Document Management Planning (DMP) and Post-Marketing Surveillance (PMS) processes within Veeva RIM.
    • Develop and maintain Veeva RIM reports, dashboards, KPIs, and performance metrics.
    • Collaborate with Regulatory Affairs, Quality, and IT teams to implement system enhancements and process improvements.
    • Support integrations between Veeva RIM and Veeva Quality applications.
    • Participate in SDLC activities, including requirements gathering, testing, validation, deployment, and production support.
    • Assist with IDMP, eCTD, and other global regulatory submission initiatives.
    • Leverage AI and automation technologies to improve regulatory workflows and operational efficiency.
    • Troubleshoot system issues, resolve user concerns, and provide ongoing functional support.
    • Ensure regulatory data integrity, system compliance, and adherence to GxP and industry standards.
    • Prepare system documentation, user guides, SOPs, and training materials.
    • Partner with cross-functional stakeholders to support regulatory operations and continuous improvement initiatives.

    Numbers & Facts

    LocationBoston, MA

    Skills

    • Artificial Intelligence (AI)unmatched
    • Automationunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Computer Scienceunmatched
    • Consultingunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Data Migrationunmatched
    • Data Qualityunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Documentation Planunmatched
    • GxPunmatched
    • Identify Issuesunmatched
    • Industry Standardsunmatched
    • Information Technology & Information Systemsunmatched
    • Maintain Complianceunmatched
    • Marketingunmatched
    • Operational Improvementunmatched
    • Operational Strategyunmatched
    • Operational Supportunmatched
    • Performance Metricsunmatched
    • Pharmacyunmatched
    • Process Improvementunmatched
    • Production Supportunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Reporting Dashboardsunmatched
    • Requirements Managementunmatched
    • Resolve Customer Issuesunmatched
    • Software Development Lifecycle (SDLC)unmatched
    • Standard Operating Procedures (SOP)unmatched
    • Support Documentationunmatched
    • Surveillanceunmatched
    • Systems Administration/Managementunmatched
    • Test Requirementsunmatched
    • Validation Testingunmatched

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