USA_Developer

Varite, Inc
  • Cambridge, MA
  • $48.14–$51.85 Per Hour
  • Instant Apply
20 days ago

Job Description

Pay Rate Range: $48.14 - 51.85/hr.

Job Description:

Lead the implementation| configuration| and support of Veeva Vault RIM Suite| including Registrations| Submissions| Submissions Archive| and RegulatoryOne modules.Collaborate with Regulatory Affairs| Clinical| Quality| and IT teams to gather business requirements and translate them into scalable Veeva RIMS solutions.Manage the end-to-end lifecycle of global regulatory submissions| registrations| renewals| variations| and health authority correspondence within Veeva Vault RIM.Configure and maintain Veeva objects| document types| lifecycles| workflows| security roles| metadata| and reporting capabilities.Drive regulatory data migration activities from legacy systems to Veeva Vault RIM| ensuring data accuracy| completeness| and compliance.Support integration of Veeva RIM with enterprise platforms such as Veeva Quality| Safety| Clinical| SAP| ERP systems| Documentum| and other regulatory repositories.Develop and execute validation deliverables including URS| FS| RTM| IQ/OQ/PQ| and testing documentation in compliance with GxP| FDA 21 CFR Part 11| EMA| and global regulatory requirements.Analyze regulatory operations processes and recommend automation| standardization| and continuous improvement opportunities to enhance compliance and submission efficiency.Provide production support| issue resolution| release management| and user training while ensuring adherence to SLAs and regulatory governance standards.Act as a subject matter expert (SME) for Veeva RIMS| advising stakeholders on best practices| regulatory data management strategies| system enhancements| and future roadmap initiatives.

Skills: Veeva Vault Platform~Veeva CRM

Experience Required: 10 & Above

 
Skills:
CategoryNameRequiredImportanceExperience
SkillCategoryTest1_MNVeeva CRMYes1>7 years 
SkillCategoryTest1_MNVeeva Vault PlatformYes1>7 years 

Numbers & Facts

LocationCambridge, MA
Salary$48.14–$51.85 Per Hour

Skills

  • Automationunmatched
  • Best Practicesunmatched
  • Code of Federal Regulationsunmatched
  • Continuous Improvementunmatched
  • Customer Relationship Management (CRM)unmatched
  • Data Managementunmatched
  • Data Migrationunmatched
  • Data Qualityunmatched
  • Documentationunmatched
  • Documentum Enterprise Content Management (ECM) Systemunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • FDA (Food and Drug Administration)unmatched
  • GxPunmatched
  • Maintain Complianceunmatched
  • Management Strategyunmatched
  • Metadataunmatched
  • Operational Auditunmatched
  • Operations Processesunmatched
  • Problem Solving Skillsunmatched
  • Process Analysisunmatched
  • Process Validationunmatched
  • Production Supportunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Regulatory Submissionsunmatched
  • Release Management/Engineeringunmatched
  • Reporting Skillsunmatched
  • Requirements Managementunmatched
  • SAPunmatched
  • Service Level Agreement (SLA)unmatched
  • System Migrationunmatched

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