Ergun Koc Email and Phone Number

I have been working for Gilead for nearly 10 years and I am experienced in publishing of different submission types including;• Centralised Precedure eCTD submissions; (MAAs, RtQs, Type IA, Type IB, Type II Variations (single, grouped, worksharing), Responses, PIPs, PSURs, FUMs)• Swiss eCTD and eDoc submissions (MAAs, LoQs, CMC Variations, Labelling, PSURs, CTAs, etc.)• National Precedure NeeS submissions• Other CTD submissions• RoW MAAs• CTAs and Substantial Amendments in EU, Switzerland, Turkey, including country specific requirements for both electronic and paper submissions.A good understanding of Validation tools and criteria for eCTD (EU & CH) and EU CTD-NeeS.I have an extensive knowledge of Insight Publisher and DocuBridge including template creation and fault diagnosis.Core Dossier, Adobe Acrobat & ISIToolbox, Xerox Nuvera, DocuColour and DocuTech printers, Xerox DigiPath, Microsoft Office suite.Document Processing and Report Publishing• Document processing of all sorts of the Regulatory documents.• EndNote Reference creation, Labelling archiving• Report level publishing of the CSRs, PSURs, ASRs, IMPDs, PSMA highly motivated, pro-active individual dedicated to customer service & delivering to strict deadlines.