Regulatory Publisher (Global Regulatory Affair and Clinical Safety) - To perform complex processes and tasks that results in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines. - Distribute aggregate reports to Pharmacovigilance, Business Partner and GCTO (Global Clinical Trial Operation) countries in accordance with aggregate report submission plan: PSUR, SUSAR, DSUR, LLR, Addendum report, Supplement etc. - Archiving aggregate reports using eDossier after distribution completion. Updating Head Quarter release date for reports through Orion (Liquent Insight) tool. - To prepare and submission of dossiers to US FDA in eCTD format. - Attend kick-off meetings, weekly team meetings and client meetings, as needed or required and jot down MOM. - QC of documents/ PDF files by using ISIToolBox: Column autovalidate, magnification inherent zoom, TOC numbering and hyperlink, bookmarks, masking, page size rotation, fastweb view, context legibility, scaling doc., files merging, PDF version, finalization in FirstDoc(RCAM), for submission. - Archive of submitted electronic documents into eDossier. - Coordinate with client business partner/CRO for timely submission of reports. Set up Protocol, Investigators Brochure(IB) and CSR VDoc (virtual documents) template into FirstDoc(RCAM) as per SOP. For Module 2, 5 updating the redacted clinical study report (CSR) documents in RCAM by EU Redaction task. Submission Reference Management (SRM) and literature search: To classify document type (Manuscript/Journal/Internal other/External other/Abstract/Conference proceeding paper) and gets publication details(Full version) from PubMed, Google, Client share point, and generate draft list of references (LOR) for submission. Assisting clients in solving queries related to above mentioned tasks. SCRUM call: Interacting with Clients twice in a week for process related queries. To prepare reports: Trackers vs. system reports, consolidated report, daily report (outstanding tasks vs. completion). ISIToolBox, Smartdesk, Adobe Acrobate professional X, FirstDoc, Lucy, Liquent InSight, Orion software.