Group Administrator: Regulatory and Quality Applications
Skills
About This Role
Overview
Provide 1st and 2nd line support for users of the Regulatory applications, E.g.
Registrations, Submissions, Archive, CRM and Safety.
Monitor support queues, investigate and resolve incidents, log service requests, and ensure timely follow-up and closure.
Troubleshoot common issues such as document upload failures, user access problems, metadata mismatches, and workflow errors.
Ensure SLAs are met, and tickets are closed on time (Incidents, Requests, Change & Problem)
Ensure Problem Management is followed, and RCA is provided for major & recurring incidents
Follow GxP & CSV methods and ensure system stays in validated state with no deviations
User Access Management
Manage user onboarding/offboarding, access rights, and role-based permissions in compliance with internal SOPs.
Assist with system audits of user access and role reviews to ensure regulatory compliance.
Incident Management & Escalation
Collaborate with other team members, management, and service providers to escalate and resolve complex technical issues.
Track and manage open issues using ticketing tools (e.g., ServiceNow), ensuring timely updates and user communication.
System Monitoring & Maintenance
Perform daily health checks and monitor system performance to ensure uptime and data integrity.
Track usage metrics, system logs, and user behaviour to proactively identify potential issues.
Documentation & Training
Maintain system support documentation including troubleshooting guides, FAQ articles, and job aids.
Assist in user training sessions and creation of quick reference materials to improve adoption and reduce support requests.
Release Readiness & Testing
Review release notes (E.g.
Veeva Release notes) and assist in testing new features and updates.
Support quarterly releases by validating critical functionality and reporting potential issues before go-live.
Continuous Improvements
Collect feedback from end-users to identify pain points and suggest system enhancements.
Participate in projects related to system upgrades, enhancements, or integrations (e.g., with Argus, ERP, or EDMS systems).
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