*Role: Business Analyst*

*Location: Thousand oaks, CA*

*Duration: long Term contract*

*Rate: $45/hr on c2c(Max)*



*send profiles to dilip.venk...@amititech.com <dilip.venk...@amititech.com>*

*Skills:*

*Primary Skills: (Mandatory) *

·         Strong working knowledge of  Regulatory Submissions

·         Substantial professional experience in the area of R&D
Information systems

·         Experience in aspects of the Regulatory Affairs process within
the pharmaceutical development organization ·

·         Experience in writing requirements for implementing\developing IT
systems supporting regulatory affairs such as document management,
electronic publishing, and submission systems

·         Relevant information systems/Business experience including
project scoping, elicitation, analysis and documentation (including
modeling) of business and technical requirements



*Secondary Skills:  *

·         Experienced in Agile development methodologies

·         Familiarity with Design Thinking and Project Management

·         Experienced in documenting requirements, data flows, elements of
business cases, etc.

·         Knowledge and experience of computer system validation, GxP and
its applicability

·         Understanding of health authority regulations





*Thanks & Regards*



*Dilip venkata*

*Amiti Consulting Corp.*

*Phone: 571-266-7906*

*Email : **dilip.venk...@amititech.com* <dilip.venk...@amititech.com>

*Url : **www.amiticonsulting.com* <http://www.amiticonsulting.com/>

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