• Prepare, compile, scan, render, and maintain regulatory submissions to Regulatory Health Authorities and other government agencies worldwide.• Format Microsoft Word documents using content templates or Microsoft Word styles consistently to prepare for eCTD publishing.• Publish documents by creating bookmarks and hyperlinks into submission files according to Synchrogenix and customer policies.• Perform quality control reviews and follow Synchrogenix procedures to identify, document and remediate findings.• Request eCTD application numbers, as needed from regulatory health authorities.• Submit electronic submissions via ESG or physical media.• Generate and submit SPL files.• Track document publishing progress for electronic submissions by using GlobalSubmit tracking tools.• Track and report time spent on completing project tasks.• Generate meeting agendas and minutes and scheduling for project meetings with clients.

- Retrieved daily request for formatting and publishing support from group mailbox by prioritizing and organizing workload. - Formatted and published anywhere from 3-15 worldwide submissions on a daily basis, depending on size and content, supporting all of Regulatory Affairs. Simultaneously, worked on long term CMC publishing projects as well as process projects representing the publishing team in Regulatory Affairs. - Managed training of temporary contracted publishers and new hires as needed. - Successfully identified risks associated with documentation, process and systems. Initiated solutions such as a rolling hand-off from authoring teams in order to accomplish successful publishing. - Accomplished on-time publishing of numerous CMC original NCE or biologic applications and in the past 8 years, successfully published three major marketing applications from NCE through the clinical phases into the major marketing applications as well as through the lifecycle and post marketing commitment applications to the FDA and EU. This included a simultaneous submission application for the NDA and MAA. - Recommended mailbox system for process of RA’s request for publishing. Became permanent standard for acquiring publishing support. - Analyzed all SOPs and Working Practices for the initiative to incorporate all global publishing SOPs and WPs with Regulatory Operations group. - Initiated a IND Kickoff Presentation for publishing group to incorporate training and information regarding company formatting standards, template storage, and MS Word preferences. This presentation proved successful by the delivery of submission documentation in the correct format, lessening formatting requirements by half the time.

Coordinated the preparation and quality control of regulatory applications and submissions with CoreDossier, Adobe, and various other types of submission softwareParticipated on project teams from Regulatory Drug Development and Clinical authors and provided electronic publishing input and guidance. Confirmed appropriate QA tasks of checking format and final output of published modules to ensure successful hyperlinking were made and dispatch of submission on electronic media. Performed any required cross-reference hyperlinking. Processed and published all types of IND and INDa, especially, Adverse Experience Safety Reporting .