Title

Fifteen years experience in the pharmaceutical industry including regulatory document and dossier publishing, project management, quality assurance, and clinical data management

Specific Areas of Expertise

·         Electronic publishing of the following complex regulatory dossier and document types:  INDs, NDAs, CTDs, ANDAs, 510Ks, DMFs, IMPDs, Annual Reports, Amendments, Orphan Drug Designation Requests, Clinical Study Reports, Investigator Brochures, Clinical Protocols, Case Report Forms, SOPs

·         Assisting in successful implementation of electronic regulatory publishing system and processes at two service organizations

·         Utilization of a variety of software for complex regulatory document and dossier publishing including, but not limited to:  MSWord, Adobe Acrobat Professional, AutopageX Adobe plug-in, CoreDossier, Image Solutions, Inc., (ISI) ISIToolBox Pharma Edition, ISIWriter templates, ISI eCTDXPress, ISIPublisher

·         Utilization of publishing equipment such as Docutech, scanners, printers, and copiers to compile and assemble paper regulatory documents and dossiers

Experience

·         Electronically published proposals, reports, regulatory documents, and regulatory dossiers using a variety of software (MSWord, Adobe Acrobat Professional, AutopageX Adobe plug-in, Reference Manager, ISIToolBox Pharma Edition, ISIWriter, ISI eCTDXPress, ISIPublisher

·      Publishing activities included formatting, proofreading and correction of typographical and grammatical errors, insertion of appendix pieces into documents, scanning, clean up of PDF files, QC of each publishing step as well as published product.

·      Performed QC of reports and regulatory documents

·      Compiled regulatory documents and dossiers for submission to clients and regulatory authorities, e.g..  compilation , printing, print QC, page numbering, tab creation, assembly/binding, label creation and application, and packing for shipment to clients and/or regulatory authorities.

Positions                          

·         Regulatory Dossier Publishing Specialist                Aptuit Consulting, Inc.

·         Global Regulatory Associate I and II                          PRA International

·         Sr. Quality Assurance Associate/Publisher            Regulatory/Clinical Consultants, Inc.