Role R&D Regulatory submission systems
Work location King Of Prussia, PA
• The person must come from IT Departments (R&D IT support) from Pharma or/and Biotech industries and should have ITIL knowledge (Incident/Change/Knowledge/Problem Management).
• In-depth knowledge of Content Management, Architecture, Administration, Regulatory Submission Process and workflows involved to publish the Clinical / nonclinical studies to governing body i.e FDA. And EMA.
• Technical skills: Documentum, DQL/SQL, Oracle.
• Knowledge of following regulatory submission applications:
§ Lorenz Docubridge
§ InSight for Publishing/Viewing
§ Veeva Vault RIMS (Regulatory information Management System)