McKenzie Ruecker Orchowski
Founder and Principal Consultant @Electronic Publishing Partners Llc
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WORK HISTORY
Founder and Principal Consultant @Electronic Publishing Partners Llc
Chandler, AZ, US
Provides eCTD regulatory submission services to clients ranging from early-stage startups toestablished biopharma companies through my independently owned consulting firm, offeringflexible pricing and expedited timelines tailored to individual project needs• Utilizes IQVIA RIM Smart, DoubleBridge Rosetta eCTD Viewer, and ISIToolBox; maintains anindependently registered FDA ESG NextGen production account• Performs document gap analysis based on application type and regional regulatory requirements• Provides exceptional client support with timely/clear communication and high attention todetail
EDUCATION
Southern Illinois University Edwardsville
Professional Science Master's, Biotechnology Management
Arizona State University
Bachelor of Science, Molecular Bioscience & Biotechnology
ABOUT MCKENZIE RUECKER ORCHOWSKI
Regulatory operations professional with over 14 years of experience publishing submissions in eCTD format using ISIToolBox, eCTDXPress, docuBridge, RIM Smart, and other software tools. Proficient in managing the assembly of complex clinical trial authorizations and marketing applications to the FDA for drugs, biologics, and medical devices. Master\'s degree in Biotechnology Management.
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