Hi, Hope you are doing Great. Kindly check the below job description and let me know if you feel comfortable. Position: Technical Lead Location: Princeton, NJ Duration: 6-12+ Months Interview Mode: Phone and Skype Mandatory Skills: Document Management, Rendition tools, pharma knowledge Job Details….. - Technical and Functional Skills on Documentum (CARA) and Publishing systems (Lorenz preferred, Parexel Insight Publisher, CSC eCTDXpress)
- Experience in Rendition tools would be preferred such as Adlib, Docshifter, LES rendition tools etc.
- Experience with integrating rendition tool with document management systems.
- Experience with Validation in a Regulated Pharmaceutical environment.
- Knowledge of URS, FRS and technical documentation is necessary.
- Knowledge on translating regulatory requirements into functional requirements.
- Experience with all major health agency (FDA, EMEA, HC, Swiss etc.) and aware of all CTD standards for regional submissions and their submission requirements.
- Strong knowledge and demonstrated working experience in Documentum, FirstDoc or CARA development/customization, deployment, and debugging.
- Have experience working on upgrade 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
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