Experience

Sanofi-Aventis U.S. LLC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager

  • Sep 2017 - Present

  Sanofi, Project Manager, External Manufacturing - Supply Chain • Product transfer – led world-wide team to ensure product packaging moved to new CMO while ensuring product remained available to customers • RFP – collected all appropriate documentation to create RFP circulated to numerous CMO’s to investigate feasibility of moving 32 products for both manufacturing and packaging. Evaluated responses and provided overview and recommendation to management. • Managed supply chain for 7 products o Interpreted product forecasts, Created Purchase orders and authorized payments, received products, created Sales orders, managed timing of shipments between air and sea. Show less



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Business Analyst

  • Jan 2009 - Mar 2016

  Led worldwide cross functional business teams to: * Establish requirements for new and later upgraded safety reporting system * Optimize the safety reporting process * Gain efficiencies in case processing * Establish and implement SOPsImplemented: * Phased delivery timelines, setting milestones and check points for business and sponsor reviewDeveloped worldwide business client relationships, earning trust and confidence.Collaborated with business and IT in managing scope, defined requirements and ensured objectives were delivered on time.Managed outsourced vendors during developmentManaged the transition of all trials (130) from legacy system to upgraded systemEnsured all documentation met System Development Life Cycle (SDLC) requirementsPrepared system for inspections and auditsImproved compliance of safety reporting Show less

• Clinical Program Integration Manager

  • Jan 2007 - Jan 2009

  Responsible for technical component deliverables for Oncology, GastroInterology, Neuroscience, (Neurology and Psychiatry), and vaccine filings, including Gardasil, ProQuad, Recombivax, Varivax and MMR.Evaluated CROs capabilities in support of Merck filings.

• Technical Services Manager

  • Jan 2006 - Jan 2007

  Managed 8 direct reports and coordinated multiple outsource engagements for clinical project technology deliverables.Established timelines with outsource vendors for due diligence, knowledge transfer, pre-SLA, and steady state and managed activities for each phase.

• Clinical Program Integration Manager / CPS Supervisor

  • Jan 2005 - Jan 2006

  Managed the delivery of the data systems for the successful completion of Merck's most critical filing - the HPV program.This included: *Data Collection * Sample Tracking * Clinical Data Adjudication

• Development Lead

  • Jan 2000 - Jan 2005

  Led data collection standards implementation and documentation efforts for 2 different technology upgrades.Led knowledge transfer efforts for each version of the newly established data collection standards.Facilitated discussions worldwide and documented requirements for a new endpoint adjudication system.Led a mega trial conversion team of over 20 people across multiple business units to convert from legacy environment to upgraded database management systems.