Providing submission-ready services, including clinical,nonclinical, CMC and regulatory documents using GlobalSubmit, Lorenz docuBridge, and Veeva; responsibilities include:o Lifecycle management, bookmarking, hyperlinking, applying OCR text recognition, verifying properPDF version and format, analysis and troubleshooting

Providing publishing services via Pyxa Solutions, including clinical,nonclinical, CMC and regulatory documents using GlobalSubmit publishingsoftware; responsibilities include:o Bookmarking, hyperlinking, applying OCR text recognition, verifying properPDF version and format• (2012-2014) Providing global labeling services via Pyxa Solutions to the labelingcompliance team of a Leading Pharmaceutical Company; primary responsibilitiesinclude:o Processing CP, DCP, MRP and National labeling updates within theirDocumentum-based repositoryo Perform cleanup of existing labeling document properties (including individualdocument attributes as well as relationships to other documents) within erepositoryfor improved document lifecycle management purposes

(2011-2012) Providing registration documentation services via Savant LifesciencesConsulting to the global submissions management team of a Leading PharmaceuticalCompany; primary responsibilities include:o Identifying and locating requested IND/NDA/MAA submission events, relatedcomponents and their applicable versions in Documentumo Creating submission history of requested IND/NDA/MAA using Data CaptureWorksheet format, which will subsequently be migrated to Liquent Insightapplicationo Providing regular updates of the Data Capture Worksheet to Shire for review andapproval

• CTD/eCTD publishing and QC of CSRs, CRFs and Clinical Summary documents forregional and global submissions in compliance with ICH E3 Guidance, utilizing thefollowing programs:o Documentum/FirstDoco Adobe Acrobat Professionalo ISIToolBoxo Virtual Link Managero eCTDXpress• Ensuring submission-ready standards – including but not limited to proper PDFversion, image deskewing, hole-punch/fax line removal, bookmarking/hyperlinkingand proper magnification settings (inherit zoom) – for all clinical documents• Troubleshooting format, cross-referencing and rendering issues in Word documents• Maintaining document lifecycle management, including study site information,issuing of templates to study teams, and version control within Documentum• Coordinating clinical publishing and submission activities for multiple study teamswith Clinical Programs, Medical Writing, and US/UK/Canada Global SubmissionsManagement personnel, as well as CROs, to ensure timely completion of CSRs andrelated clinical documents for regulatory submissions• Evaluating new CROs for current and future publishing work, and providing costestimates for outsourced work• Locating and providing electronic files in timely manner for internal audits as well asregulatory agency inspections• Metrics tracking to gauge current workload and future resource needs• Assisting Global Submissions Management with daily submissions andIND/NDA/MAA submissions on an as-needed basis• Evaluating new publishing applications and participating in systems validation testing• Participating in development, implementation and maintenance of naming standards,as well as publishing practices and procedures for CSRs and related clinicaldocuments• Ability to identify process improvements and implement accordingly• Training/mentoring of staff

• Supporting global projects leading to global filings• Publishing and indexing of AE, IND, NDA, sNDA submissions according to internalSOPs and FDA/ICH Guidelines• Bookmarking and hyperlinking using CoreDossier, ISIToolBox• Proficiency in Documentum, Windows NT, web-based applications• Ability to read and understand various regulatory document types• Ability to work on multiple submissions and projects simultaneously• Serving as knowledge expert on regulatory format requirements• Providing expertise in document searching with regards to regulatory lifecyclemanagement, litigation, divestiture, general requests• Performing QC of paper and electronic regulatory submissions• Ability to identify and resolve issues relating to publishing and indexing• Performing electronic document migration and clean-up• Compile and report statistics on a regular basis for compliance purposes• Participated in pilot project for Data Exchange Architecture (DEA), which wasdesigned to submit MedWatch reports to the FDA electronically