Senior Technical Editor, Electronic Document Coordinator/Specialist

8/2001 - 4/2010

Sanofi-aventis

Individual Contributor

• Responsibilities performed, but not limited to: - In collaboration with the Medical Writer, provide support and assistance in the collection, review, preparation, and assembly of documentation required such as: -- Protocols and Amendments -- Investigators’ Brochures (IBs) -- Clinical Study Reports (CSRs) -- Supplements -- Statistical Analysis Reports (SAPs) -- Literature references -- Subject narratives/profiles -- Integrated summary modules -- Appendices -- IMPDs, IND/CTA, and others - Retrieve, format, and if needed, QC statistical output for in-text tables/figures/listings and integrate these elements into electronic document templates. Ensure that tables/figures/listings are delivered and inserted properly to avoid “corruption” of documents - Troubleshoot background template codes for correct usage - Provide flawless quality with regard to grammar, punctuation, readability, clarity, organization, format consistency, style, flow, and adherence to departmental templates, guidelines, styles, and processes - Utilize electronic documentation management system (Documentum), Adobe Acrobat Professional 9, ISI toolbox, Compose, and submission publishing tools (Core Dossier) to assemble and publish general submission documents - Review and approve submission documents for eCTD compliance - Prepare final electronic PDF navigational competencies to all documents by applying blue-text, bookmarks, and hypertext linking to better accommodate Regulatory/FDA reviewers at time of submission - Manage the quality control of all blue-texted, bookmarked, and hyperlinked documents prepared for electronic submissions Additional responsibilities performed, but not limited to: - At initial onset of study report inception, prepare “front-ending” of CSRs (cutting and pasting information from protocols and amendments, changing present tense to past tense, compiling List of Abbreviations at first use) for first draft review by project team - Participate and work on other various individual and team projects - Assist in providing departmental support in the form of suggestions, options, and feedback to various other departments, projects, and teams - Ensure concise usability and functionality of electronic products and identifying any issues that could impact the final publishing process of documents - Engage in ongoing education and awareness of development in all Therapeutic Areas (TAs) represented in the company

9/1979 - 5/2001

Systems & Computer Technology Corporation (now SunGard)

Individual Contributor

• Responsibilities performed, but not limited to: - Revised, updated, and maintained company proposal “boilerplate” documents, staff curricula vitae’s (CVs), client profiles, and “frequently used language” library - Coordinated activities and documentation preparation necessary to ensure the fulfillment of Request for Proposal (RFPs) documents within the established timeframes - Coordinated and distributed mass mailings (print letters, envelopes, attachments) - Printed, copied, assembled, and shipped RFPs - Prepared, printed, and bound color presentations as required for potential new prospects and conferences (prepared for in-house Marketing and Sales departments) - Designed company standards for presentations such as agendas, surveys, logo covers, flyers, and forms - Performed routine maintenance activities on Xerox Color Printer/Copier - Provided word processing and desktop publishing assistance to the operators on inputting and revising of documents - Provided high quality accuracy and professionalism to all documents being generated by the department - Trained operators in the proficient use of graphics software tools - Designed and provided standard company policy and procedure guidelines for company document setup and format - Maintained concise records of all incoming and outgoing projects for accurate tracking of documents - Monitored and maintained the accuracy and soundness of all software and services (print, communications, file validity) residing on the newly acquired Xerox 8000 Network (a form of internal “doc base”), consisting of a 300MB File Server with a 300MB Backup Volume storing approximately 3000 documents - Troubleshot and resolved any problems that could have occurred with the above software and services

1967

High School/GED Degree

Sharon Hill Senior High School

• Business Administration