Responsible for creation and publishing of both global paperand electronic submissions including NDAs, INDs, AnnualReports, Periodic safety reports, Supplements, Variations,Responses, etc.• Technical knowledge of electronic publishing systems andtools (ISI Publisher, Lorenz eValidator, Phlex pharma, CARA prism Publisher).• Responsible for pre-publishing ( Bookmarks, hyperlinks,compilation and Validation).• Proficiency with MS-Office Suite, and Adobe Acrobatapplications.• Represent on project team meetings, driving timelinesand deliverables related to publishing and submissiondocuments.• Maintain knowledge of the regulations and maintenance ofcontrolled documents required by the USFDA and ICH.