US_East | Desktop Support_L3

R2D2 9506997 Role R&D Regulatory submission systemsWork location: King Of Prussia, PA (Remote)Rates as follows: $78/hrBackground Check: MANDATORYR&D Regulatory submission systemsLocation: KOP (King Of Prussia) / RemoteRole Description:L2/L3 Support: Service requests, incident resolution, release management, minor enhancement on list of regulatory submission applications.Performing Computer System Validation activities and authoring documents for regulatory submission systems in the Biotech/Pharmaceutical IndustrySkills Requirements: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).Some knowledge of and experience in Regulatory Information Management System Administration, Regulatory Submission Process and Regulatory Affairs business processes workflows involved in interaction with Health Authorities i.e FDA. And EMA.Technical skills: Windows Server, Documentum, DQL/SQLKnowledge of following regulatory submission applications preferred: Lorenz Docubridge InSight for Publishing/Viewing Veeva Vault RIMS (Regulatory Information Management System)Key Words (for sourcing): Pharma or/and Biotech, Regulatory Affairs Regulatory SubmissionsVIDEO INTERVIEW IS MANDATORY -ERM – Miguelangel Buonafina | Capgemini |North America Tel.