A highly motivated professional who effectively co-ordinates assigned publishing projects in theRegulatory and Technical department.With 17+ years of experience, this professional effectively delivers these skills onsite at variouscompanies, lending her keen ability to quickly adapt to and utilise each company’s individualdocument management and publishing tools to produce submission-related documents including:IND Amendments, Investigator Brochures, CSRs (Phase I – IV), INDs, NDA/eNDAs, BLA/eBLAs,CTDs, eCTDs, NDS, CTAs and various submission-related documents as necessary.Specialties: Application ExperienceeCTD-ManagerInsighteSub-Livelink & LiveLink (repository)CoreDossier 3X, 4X, 5XMS Word 97, 2000 and 2002 (XP)MS Excel and PowerPointAdobe Acrobat 3 - 7Imaging ProfessionalCitrixISIToolBox PharmaPublishing Experience:eCTDNDSNDA/BLA (paper and electronic)MAA ComponentsNDS ComponentsCTD IND Phase I-IV CSR (paper and electronic)Investigator BrochureProtocol and Protocol AmendmentsAnnual ReportsMeeting Information Packages