We are looking for Veeva Vault - Regeneron Consultant for our client in Princeton, NJ
Job Title: Veeva Vault - Regeneron Consultant
Job Location: Princeton, NJ
Job Type: Contract 12 Months
- Technical and Functional Skills on Enterprise Content Management tools, Veeva Clinical tools (Veeva CTMS and Veeva eTMF) and Publishing systems (Veeva Vault Submission, Veeva Submission Archive, Veeva Labeling, CSC eCTDXpress)
- 7+ years of total IT experience and 5+ years of experience in Regulatory Submission Technologies
- 5 years of experience with Regulatory Submission Validation systems (GlobalSubmit, Lorenz, Extedo, ISI Toolbox)
- Experience with Validation in a Regulated Pharmaceutical environment
- Knowledge on translating regulatory publishing requirements into functional requirements.
- Knowledge on cloud based technology and SaaS model.
- Experience with all major health agency (FDA, EMEA, HC, Swiss etc.) and aware of all CTD standards for regional submissions.
- Strong knowledge and demonstrated working experience in Documentum, FirstDoc development/customization, deployment, and debugging.
- Have experience working on support and maintanence projects and assessing the system in integrating other applications.
- Participates in change management, disaster recovery and production support operations
- Comfortable working in Java, PL/SQL, DFC/DQL, Java Script and RDMS concept.
- Worked on Change Control Procedure
- Pharma domain knowledge is required and should be aware of GxP processes