Naseer Shaik
Team Lead Im & s Technical Services @Novartis
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WORK HISTORY
Team Lead Im & s Technical Services @Novartis
Hyderabad, IN
EDUCATION
Sri Chaitanya Junior College
Intermediate, Bi.P.C, A
NTR University of Health Sciences
Bachelor's degree, Medical Lab Technology, B
Krishna University
Master of Science (M.Sc.), Microbiology, General, A
ABOUT NASEER SHAIK
Having a clear understanding of the regulatory guidelines of different regulatory agencies including EMA and FDA. • Experience in source document formatting, PDF conversion, bookmarking and hyperlinking, report level publishing and submission level publishing. • CRFs – Bookmarking and Hyperlinking • Experience in Lifecycle management and validating submissions • Planning for eCTD, Paper and NeeS submission • Creating, maintain and updating Clients documents in Work Zone • Reviewing submission document as per the submission planner before processing • Publishing activities (Compilation of Application as per submission planner, Assigning documents, entering metadata, Publishing of eCTD and NeeS Submissions to various Agencies) • Post Publishing activities (inter-document hyperlinks, Smart Linking & Validation of submission) • Clinical Study Report Publishing – Publishing CSR as per the ICH E3 guideline
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