Ms. Orchowski comes to Biologics Consulting with over 5 years of regulatory submission experience. She is proficient in managing the assembly of complex clinical trial authorizations and marketing applications for submission to the FDA for drugs, biologics, and medical devices.
Mckenzie previously worked for Translational Drug Development (TD2), an oncology contract research organization, and gained experience working with cross-functional teams to plan and track the preparation of initial IND applications. She also assisted with content compilation and Word formatting of Type B meeting requests and briefing packages, as well as orphan drug designations and annual reports.
Prior to TD2, she worked for Arivis (formerly known as Mission3) as their Regulatory Operations Manager. In this role, she managed the publication and validation of all client eCTD submissions using a home-grown publishing software solution. Mckenzie directly contributed to the enhancement of this system by interfacing with the software development team to compose test-driven user requirements.
Ms. Orchowski gained extensive experience as a Senior Publishing Specialist at Medicis Pharmaceuticals, where she acted as primary liaison to coordinate the outsourcing of large eCTD submissions, including an original 505(b)(1) NDA. Mckenzie also published an initial IND application and an original 505(b)(2) NDA and prepared lifecycle submissions for over 27 products (in paper, eCopy, and eCTD format), including supplements, amendments, periodic safety updates, and promotional material submissions for INDs, NDAs, BLAs, ANDAs, IDEs, and PMAs.
Ms. Orchowski received her B.S. in Molecular Bioscience and Biotechnology from Arizona State University in 2007 and her M.S. in Biotechnology Management from Southern Illinois University Edwardsville in 2010.
MS, Biotechnology Management, Southern Illinois University Edwardsville, Edwardsville, IL (2010)
BS, Molecular Bioscience & Biotechnology, Arizona State University, Tempe, AZ (2007)