Job Description :
8-10 years of experience with Regulatory Submission/Publishing systems (Lorenz preferred, Parexel Insight Publisher, CSC eCTDXpress)
5 years of experience with Regulatory Submission Validation systems (GlobalSubmit, Lorenz, Extedo)
Experience with Validation in a Regulated Pharmaceutical environment
Knowledge on translating regulatory publishing requirements into functional requirements.
Knowledge in designing of publishing systems.
3-5 years of experience with EMC Documentum
Experience with all major health agency (FDA, EMEA, HC, Swiss etc and aware of all CTD standards for regional submissions.
Experience with SQL, DQL and RDMS concepts.
Extensive Exposure to health care and Health Care Domain Expertise