Veeva Vault - Regeneron Consultant

Cynet Systems   •  

Princeton, NJ

Industry: Technology

  •  

8 - 10 years

Posted 35 days ago

  by    Cynet Sytems

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

Job Description:

  • 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