Amsterdam, North Holland, Netherlands
- Ensuring of creation of regional submission packages and organizing of the work-sharing of publishing tasks (eCTD/NeeS) in a global matrix organization - Establishing, maintenance and improvement of publishing systems and best practices in compliance with GxP and global submission -requirements
SME for: - Regulatory Data and Document - Management and Archiving - Regulatory Submissions (eCTD / NeeS / Paper) - Business Administrator/Trainer for RA eDMS (OpenText ECM) - Business Administrator/Trainer for RA Correspondence Repository (SharePoint)
- Global SME for Regulatory Data and Document - Management and Archiving - Planning of Regulatory Submissions and Submission Management (eCTD / NeeS / Paper) - Publishing of Regulatory Submissions (Insight Publisher) - Coordination of off-site publisher - Business Administrator and Trainer for regulatory eDMS (OpenText) - Contribution in Projects to improve the reg. Archives
- Subject Matter Expert for Regulatory Submissions (eCTD / NeeS / Print) - Planning of Regulatory Submissions and Submission Management - Publishing of Regulatory Submissions (Insight Publisher / Coredossier) - Coordination of off-site publisher - Business Administrator of the Regulatory Tracking Database (Trackwise) - Business Trainer for eDMS (Livelink) - Contribution in Project to improve the Quality and Planning of RA tasks - Operational Records Manager - Information Security Coordinator
- Regulatory Submission and Dispatch Management (CTD) - Publishing of Regulatory Submissions (Coredossier) - Trainer for Regulatory eDMS (Livelink) and Database (Trackwise)
- Maintaining of Labeling texts - Maintaining of Packaging Material - Organization of Translations