Extensive Experience with standard industry software and systems:

• Electronic Document Management Systems – Documentum, Livelink, and Lorenz docuBridge
• Publishing Systems – CoreDossier, EZsubs, Lorenz docuBridge, Insight Manager, Insight Publisher, and CRFTrack
• Adobe Tools – Acrobat Professional, ISI Toolbox (Standard and Pharma), Compose, Photoshop
• Microsoft Products – Office (Word Templates, Excel Databases) , Access, Visio
• FDA Electronic Submissions Gateway (ESG)
  

Extensive industry experience in submitting all formats of regulated information to global regulatory authorities, including:

• Investigational Applications (IND, eIND, and CTA)
• Marketing Applications (NDA, eNDA, MAA, and eCTD)
• Promotional Materials
• Labeling (SPL, PLR)

CVs Available upon request