1. JEAN-PIERRE MAINGUY, PH.D.
South Pasadena, CA 91030
jpmainguy@gmail.com
626-347-0752
S U M M A R Y
Principal IS Business Analyst and project manager. Extensive experience in the
Bio-Medical field with emphasis on Regulatory and Safety Information Systems
management and system validation. S uccessful track record in managing substantial
programs and project teams through the system life cycle on time and on budget.
Hands-on experience in Biopharmaceutical research and development processes,
validated information systems, and ICH and FDA guidelines for regulatory submissions.
• Project Management • Team Building • Finance and Planning
• Strategy and Analysis • Regulated Systems • System Validation
• Metrics and Reporting
• Technology Evaluations
• Regulatory & Safety
• System Life Cycle
• ITIL
• Change Management
P R O F E S S I O N A L E X P E R I E N C E
SyNRG Solutions: 2015 to present
Senior Information Systems Business Analyst: Oracle Argus Safety specialist.
AMGEN, Inc. Thousand Oaks, CA 2006 to 2014
Global Biopharma company
Global regulatory & Safety 2010 – 2014:
Safety Compliance Program: Developed safety submission process to respond to
changing requirements in regulations. Implemented the new European GVP
guidelines. Oracle Argus Safety specialist.
Migrated the Global Safety Notification portal to the new Intralinks platform. The
application is serving over 18,000 clinical trial investigators, safety contacts and
study coordinators located at Amgen clinical trial sites worldwide. The
users can access the system from any device: PCs, iPAD or iPhone.
R&D Informatics Project Manager 2006 - 2010:
Safety Compliance Program: lead project manager for Amgen implementation and
deployment of Oracle Argus Safety. Configured reporting rules for automated
submission of expedited safety reports to Health Authorities, Business Partners,
Ethics Committees and Investigators. Ensure compliance with EMA, ICH and FDA
guidelines. Argus Safety was successfully deployed worldwide for all Amgen
products.
Developed Global Safety Notification Portal for the submission of expedited safety
reports to investigators on clinical trials worldwide. Lead safety project manager. ν
Delivered the requirements analysis for a new medical terminology management
system for Amgen safety surveillance and clinical data management based on

2. MedDRA .
Completed business process re-engineering of Clinical Study Report processes
from study start to submission.
Developed and released a new Regulatory Knowledge Base (RKB) for the Global
Regulatory Intelligence and Policy department.
Implemented the new release of Liquent CoreDossier publishing software for
regulatory submissions
Technology Management Consulting 2002 to 2006
Research Associate, Claremont Graduate University – contract position
• Managed IS projects for enterprises in Southern California.
• Researched and project management on web collaboration for biomedical
applications, in partnership with City of Hope.
• Created a database for Proteomics and Genomics experiments for the Keck
Graduate Institute for Life Sciences, Claremont, CA
Learning Tree International.
Taught Project Management for Software Development
Pepperdine University Business School, Adjunct Faculty
Taught Management of Information Systems in the professional MBA program.
University of Redlands Business School, Adjunct Faculty
Taught International Business and project management courses in the professional
MBA program
Hewlett-Packard Company, 1998 to 2002
Palo Alto, CA
Manager, Corporate IT Extended Enterprise Services
Managed a worldwide team of 60 engineers to deliver new secure services for
business partner integration, EDI, and e-commerce hosting.
Developed secure virtual private network service for business partners, and single
login solution for HP.com worldwide.
Implemented initial website infrastructure for HP.com worldwide, reaching one
million visitors per week in six months.
Developed new internet application hosting services for SAP and PeopleSoft in
HP outsourcing division.
Manager, Corporate IT Network and Telecom Operations Europe
Managed European Network and Telecom operations in 15 countries.
Consolidated HP’s international telephone services in Europe to single Virtual
Private Network solution.
Ensured compliance and evolution of HP’s security audit policy in Europe.
Deployed service life cycle process, and usage-based billing throughout European
operations.

3. Deployed remote network access, and secure GSM mobile data for employees and
partners in Europe.
E D U C A T I O N A N D C E R T I F I C A T I O N S
Ph.D. Biomathematics, with honors. University of Rennes, France
Masters of Science. Mathematics, University Pierre & Marie Curie. Paris,
France
Languages: English, French and German.
Amgen Safety Training and Certification: Safety Compliance curriculum. Oracle
Argus Safety. Intralinks Secure Platform.
Amgen IS Training and Certification: System Validation. IS Change and Release
Management (Service Now). Quality Control (HP Quality Center). Rational Unified
Process (RUP).
Biomedical data standards: SNOMED International Clinical Terms training.
MedDRA coding. CDISC Coding Certification.
Project Management: Certified Project Management Professional (PMP)
City of Hope: Certified GeneSpring Gene Expression Analyst. NCBI GenBank
Proteomics and Genomics Database training.
Hewlett-Packard: Quality Management System
T E C H N I C A L S K I L L S A N D O T H E R
• Microsoft Office Suite • MS Project • Argus Safety
• HP Quality Center • Service Now • PL/SQL
•
A F F I L I A T I O N S
Project Management International (PMI). Current member.