Agiloft & ComplianceWire Support Associate

 Posted 2 hours ago
  
 Canada
  
2-5 years experience
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AI Summary

Provide functional and operational support for Agiloft and ComplianceWire systems within a regulated life sciences environment. Manage content review workflows, training assignments, and ensure compliance with GxP and regulatory requirements.
Position Summary
We are seeking a detail-oriented Agiloft & ComplianceWire Support Associate to provide functional and operational support for training, compliance, and content review workflows within a regulated life sciences environment. This onshore role will support end users, maintain system integrity, and ensure compliance with GxP and regulatory requirements across Agiloft (MLR/PRC workflow) and ComplianceWire (LMS).
 
Key Responsibilities
AgileLoft (MLR/PRC) Support
  • Provide day-to-day support for AgileLoft users, including content routing, workflow management, and issue resolution
  • Assist with setup and maintenance of review workflows, user roles, and permissions
  • Troubleshoot submission, approval, and annotation issues within MLR processes
  • Support content lifecycle management, including versioning, tagging, and archiving
  • Partner with Marketing, Medical, and Legal teams to ensure timely review cycle completion
ComplianceWire (LMS) Support
  • Administer and maintain ComplianceWire training assignments, curricula, and user records
  • Support onboarding/offboarding activities and training compliance tracking
  • Troubleshoot user access, training completion, and reporting issues
  • Generate and distribute compliance reports for audits and internal stakeholders
  • Ensure training records align with regulatory and audit requirements (GxP, FDA, etc.)
Cross-Platform & Operational Support
  • Serve as first-line support for system-related inquiries and escalate issues as needed
  • Maintain system documentation, SOPs, and job aids
  • Support data integrity, validation activities, and audit readiness efforts
  • Collaborate with IT, QA, and vendors for system enhancements and issue resolution
  • Monitor system performance and proactively identify improvement opportunities
Required Qualifications
  • Bachelor’s degree in Life Sciences, Business, IT, or related field
  • 2+ years of experience supporting AgileLoft, ComplianceWire, or similar platforms (MLR/PRC tools and LMS systems)
  • Strong understanding of content review processes and training compliance in regulated environments
  • Experience with user support, ticketing systems, and issue troubleshooting
  • Proficiency in Excel and reporting tools
  • Strong attention to detail and documentation skills
  • Ability to work PST hours and collaborate with cross-functional teams
Preferred Qualifications
  • Experience in pharmaceutical, biotech, or medical device industries
  • Familiarity with GxP, FDA regulations, and audit readiness processes
  • Experience with Veeva PromoMats, Veeva Vault, or other MLR systems
  • Knowledge of data governance and compliance frameworks
  • Exposure to validation processes (CSV) or system release management
Key Competencies
  • Strong problem-solving and troubleshooting skills
  • Effective stakeholder communication and support mindset
  • High attention to compliance and data accuracy
  • Ability to manage multiple tasks in a fast-paced environment
  • Process-oriented with a continuous improvement mindset

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