Senior eSubmission Manager
Certified Project Manager, IPMA (2007)
Diploma in Business Organisation, Copenhagen Business Academy (1998)
Medical Secretary, Nykøbing F. Hospital (1980)
Helle Ørbæk has been with IWA Consulting for 12 years and is part of the Regulatory Operations Team. She has extensive experience in eCTD strategies and compiling including joint EU and US eCTD Projects using docuBridge as the eCTD tool. Furthermore she is specialized in Document Management and Regulatory IT solutions and has extensive experience in Quality System Management (DS/EN ISO 9001).
For more information about Regulatory Operations Team click here.