Description:
Possible 3 Month CTH | No Fees | Do Not Re-Post| Confidential
R2D2 9506997
Role R&D Regulatory submission systems
Work location King Of Prussia,PA (Remote)
Rates as follows: $ 78 hr/AI
Background Check: MANDATORY
R&D Regulatory submission systems: R&D Regulatory submission systems
Location: KOP (King Of Prussia) / Remote
Role 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 Industry
Skills 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/SQL
• Knowledge 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 Submissions
**VIDEO INTERVIEW IS MANDATORY
-ERM - Miguelangel Buonafina | Capgemini |North America
Tel.: +1 888-229-2961 Ext 13578