Mckenzie Orchowski
Phoenix,AZ
Overview
15
15
years of professional experience
Work History
Associate Director of Regulatory Operations
Biologics Consulting Group, Inc.
07.2020 - Current
- Assists the Director of Regulatory Operations with scheduling client submissions and delegating publishing work to team members across multiple time zones
- Assists the Electronic Publishing Coordinator with formatting of Word documents, creating/maintaining submission trackers, and troubleshooting document-level queries or technical issues
- Responsible for training new hires and current employees on company processes/procedures, as well as emerging regulatory requirements and data standards, such as the US Regional DTD v3.3 and the study data Technical Rejection Criteria (TRC)
- Drafts proposals and provides publishing estimates for multi-disciplinary projects
- Publishes original applications for INDs, BLAs, NDAs, ANDAs, and Master Files in eCTD format
- Publishes maintenance amendments for existing applications and performs QC/validation of output
- Transmits submissions to the FDA via the Electronic Submissions Gateway (ESG)
- Provides exceptional client support with timely/clear communication and high attention to detail.
Electronic Publishing Specialist
Biologics Consulting Group, Inc.
05.2016 - 07.2020
- Published original applications for INDs, BLAs, NDAs, ANDAs, and Master Files in eCTD format
- Published maintenance amendments for existing applications and performed QC/validation of output
- Transmitted submissions to the FDA via the Electronic Submissions Gateway (ESG)
- Other duties included SOP development, assisting with software evaluations and training of new hires, minor formatting of Word documents, and miscellaneous administrative duties as requested.
Regulatory Operations Manager
Translational Drug Development (TD2)
08.2015 - 05.2016
- Acted as project manager for all client regulatory projects, working with regulatory affairs and cross-functional teams to plan and prepare both simple and increasingly complex submissions
- Developed and maintained detailed multi-functional Gantt charts using Microsoft Project
- Responsible for the formatting of submission components using Microsoft Word and performed pre-publishing activities in Adobe Acrobat Pro using ISIToolBox to create internal navigation (i.e., bookmarks and hyperlinks) according to industry best practices
- Assembled all client regulatory submissions [e.g., IND applications, protocol amendments, safety reports, annual reports, orphan drug designation requests, etc.] in both paper and eCTD format using cloud-based publishing software docuBridge for submission to the CDER Division of Oncology
- Obtained a WebTrader production account for each client and used a digital encryption certificate to submit through the FDA Electronic Submissions Gateway, archiving all receipts and acknowledgements in various document management systems (i.e., ShareFile and SharePoint).
Regulatory Operations Manager
Arivis AG (formerly Mission3, Inc.)
11.2013 - 08.2015
- Responsible for the management and publication of all client eCTD submissions using a home-grown publishing software solution, Clireo eCTD, formerly known as FastCrossing
- Attended weekly meetings with clients to provide subject matter expertise and issue resolution
- Directly contributed to the enhancement of FastCrossing by interfacing with the software development team and drafted user requirements for the eventual deployment of Clireo eCTD
- Participated in the development and enhancement of internal processes through the creation of SOPs, work instructions, style guides, and templates
- Represented the company in communications with the FDA eSub group regarding technical aspects of electronic filings and requested pre-assigned application numbers on behalf of clients
- Maintained knowledge of current regional legislation to ensure regulatory submissions were in accordance with electronic specifications and/or standard industry practice by participating in webinars and attending hands-on workshops.
Senior Publishing Specialist, Regulatory Affairs
Medicis Pharmaceutical Corporation
08.2011 - 11.2013
- Acted as primary liaison to coordinate the outsourcing of large eCTD submissions to Quintiles, including an original 505(b)(1) NDA of approximately 65,000 pages
- Published an initial IND and 505(b)(2) NDA using in-house publishing software eCTDXPress, following ICH guidelines regarding the structure and content of clinical study reports
- Prepared lifecycle submissions for over 27 products (in both paper and eCTD format), including supplements, periodic safety updates, and general correspondence, for INDs, NDAs, and ANDAs, authored in Octagon’s StartingPoint templates
- Created eCopies to accompany paper submissions to CDRH for medical devices under IDEs and PMAs
- Collaborated with Creative Services Department to prepare promotional material for submission to OPDP, averaging over 500 individual promotional pieces (in both paper and electronic format) every year
- Navigated the web-based eFiles system of Health Canada’s Pharmaceutical Advertising Advisory Board (PAAB) to upload promotional material (in English and French) for review and acceptance
- Provided cross-functional training to Pharmacovigilance and Compliance Departments on utilizing the ESG for expedited adverse event reporting and submittal of drug sample information
- Archived submissions, FDA correspondence, and contact reports in 21 CFR Part 11-compliant document management system (i.e., Documentum).
Adjunct Faculty & Student Learning Facilitator III
Maricopa County Community Colleges
01.2011 - 12.2011
- Initially employed part-time as a science tutor in GateWay Community College’s Learning Center, providing appointment-based and drop-in tutoring for biology, chemistry, physics, and math courses
- Proceeded to accept an offer to teach one semester of BIO 156: Introductory Biology for Allied Health at Paradise Valley Community College as an adjunct faculty member
- Included bi-weekly lectures and a weekly four-hour laboratory session
- Prepared presentations, comprehensive exams, lab exercises and practicals, homework assignments, and all other course materials.
Scientific Business Analyst
Monsanto Corporation
06.2009 - 12.2009
- Completed a six-month co-op in the Technology Pipeline Solutions department as part of graduate coursework
- Offered an extension for the month of December
- Led meetings with Regulatory Compliance Specialists to gather reporting requirements
- Delivered test-driven requirements for multiple Business Objects reports using Worksoft Certify, providing insight into field trial management and transgenic plant material regulation status
- Spearheaded projects to improve the on-boarding process and auto-generation of test scenarios.
Education
M.S. - Biotechnology Management
Southern Illinois University Edwardsville
01.2010
B.S. - Molecular Bioscience & Biotechnology
Arizona State University
01.2007
Websites
Fax
703.548.7457
Presentations
- Publishing Datasets: What You Need to Know (and What You Don't Need to Know), DIA RSIDM Conference, 02/14/22, North Bethesda, Maryland
- Moving to eCTD in the Cloud: Lessons Learned, DIA EDM-ERS Conference, 09/22/14, Washington, D.C.
Personal Information
Title: Associate Director of Regulatory Operations
Publications
- Pre-IND Meeting Requests for COVID-19 Products, Biologics Consulting Blog, 07/01/20
- Are You Ready for the eCTD Mandate?, PDA Letter, Parenteral Drug Association, 07/01/18, 56-57, https://www.pda.org/pda-letter-portal/home/full-article/are-you-ready-for-the-ectd-mandate
Timeline
Associate Director of Regulatory Operations
Biologics Consulting Group, Inc.
07.2020 - Current
Electronic Publishing Specialist
Biologics Consulting Group, Inc.
05.2016 - 07.2020
Regulatory Operations Manager
Translational Drug Development (TD2)
08.2015 - 05.2016
Regulatory Operations Manager
Arivis AG (formerly Mission3, Inc.)
11.2013 - 08.2015
Senior Publishing Specialist, Regulatory Affairs
Medicis Pharmaceutical Corporation
08.2011 - 11.2013
Adjunct Faculty & Student Learning Facilitator III
Maricopa County Community Colleges
01.2011 - 12.2011
Scientific Business Analyst
Monsanto Corporation
06.2009 - 12.2009
M.S. - Biotechnology Management
Southern Illinois University Edwardsville
B.S. - Molecular Bioscience & Biotechnology
Arizona State University
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