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Keywords / Skills : ISI eCTD express, Liquent Insight Publisher, PharmaReady, & Lorenz application

3 - 6 years
Posted: 2019-03-03

Industry
Recruitment/Staffing/RPO
Function
IT
Role
Software Engineer/ Programmer
Posted On
3rd Mar 2019
Job Ref code
262
Job Description
Job Description:

3yrs exp in regulatory operations with hands on experience in Publishing tools like ISI eCTD express, Liquent Insight Publisher, PharmaReady, & Lorenz application apart from the Reg submissions exp.Desired Profile:

eCTD/ CTD/ NeeS submission compilations
Worked on electronic or paper submissions
NDA, IND, ANDA, MAA, CTA, Amendment Submission, supplemental, Variations, Response to HAs, Follow-up measures, Annual Reports
Countries worked US, EU, ROW, International, Australia, South Africa.
Labeling, Structured product labeling, labeling Submission; XML backbone Metadata etc.
Publishing Tools worked on :- ISI publisher , ISI toolbox, ISI eCTD Xpress, Insight Publisher, PharmaReady, Educe, DocBridge, Extedo; eCTD Complier/ Publisher; CH SwissMedic eCTD complier etc.

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