Todd Philipps Email & Phone Number

Greater Chicago Area

eSubmissions consulting company focused on electronic Isubmissions to FDA.Main expertise entails eCTD publishing, buisness process development, SPL & XML generation.

Irivne, CA

• Lead implementation of MedXview eCTD software. Transitioned from paper submission environment to fully GxP validated eCTD environment within 6 months of project start.
• Responsible for all eCTD publishing, submission, archival and regulatory information activities.
• Developed Regulatory Operations role. Established eSubmission processes, archival processes and regulatory information management, eSubmission and SPL SME roles.
• Digitized complete paper library providing Anchen employees and off-site partners access to all submission documents from their desktop. Converted 415 paper volumes to 18 gigabyte of online data.
• Structured Product Labeling (SPL) subject matter expert including SPL for draft labeling submissions, drug listings, content of labeling and establishment registration.
• Implemented TVT tool suite to aid document reviews and comparisons. Saving an average of 8 hours review time per comparison with an average of 4 comparisons per labeling submission. Also providing 99.9% accuracy.

West Coast

• Develop Best Practice, Insider Tips & How-to documents for use on ISI’s support portal ISIOnCall
• Provide business process and best practice recommendations regarding eCTD/CTD dossiers to ISI clients
• Provide clients with Regulatory guidance interpretations, flexibilities, and requirements
• Write custom work instruction documents on a client-by-client basis to include business process, software processes and regulatory information
• Conduct Business process workshops to enable customers to develop/refine business processes as they relate to Electronic Submissions
• Provide software specific training to customers for ISI such as: Introduction to eCTD, ISIWriter, eCTDXPress, ISIPublisher, Technical Administration

• Business lead for Corporate-wide Electronic Submission (eCTD) software implementation. Cost savings of over $560,000/year for Corona Site.
• Defined user requirements, user acceptance testing procedures and SOPs for eCTD and Electronic Submission Gateway (ESG) systems.
• Developed and conducted software training covering all aspects of new software systems. Personally trained approximately 75 people.
• Defined and published Business Practice guidelines covering both Pre-Approval submissions and Post-Approval Submissions
• Subject Matter Expert supporting 4 corporate sites across the US.
• Managing integration of off-shore eCTD submissions into corporate systems.

• Manage Quality Assurance server / environment administration and product delivery functions providing stable and reusable environments for testing.
• Manage 10 servers including Web and Database servers for product validation and issue verification activities.
• Extensive experience in SDLC including gather customer requirements, investigating customer business scenarios, writing requirements, actual development, QA activities and onsite customer installations.
• Managed development efforts between USA and India Office, including offshore team of 8 engineers with local team of QA, Database and Marketing.
• Delivered initial Reporting Product in 7 months, after existing team labored 2 years with no success.

• Teamed with marketing department to define requirements, design and scope of projects.
• Managed 12 team members on multiple tasks across multiple projects.
• Maintained and supported ecommerce websites and servers, averaging over 10 million unique visitors per month and 75,000 orders per week.
• Successfully integrated 3rd party tools into websites through collaborative efforts with vendors, credit card clearing and home sales data.
• Managed new development, maintenance, server administration and database administration.
• Converted all company sites from Perl & FoxPro to ASP & SQL Server 7.0.

• Developed and provided support for ISU’s AccessPlus, an interactive Student Information System available via web browser or campus Kiosks that averages 165,000 hits per month
• Worked as webmaster for ISU dealing with problem resolutions, upgrades and client support.
• Developed, implemented and maintained batch programs in support of numerous CICS systems, using CA-Easytrieve and COBOL
• Conducted systems analysis, design and programming with MVS computer systems supporting ISU’s Human Resources Department

Ba, Computer Information Systems

Activities and Societies: Track and Field team 1984

High School Diploma