Mckenzie Orchowski Email & Phone Number

Provides eCTD submission outsourcing and regulatory operations consulting services, with a focus on accurate, compliant, and timely regulatory submissions for pharmaceutical and biologic product applications to the FDA

Alexandria, Virginia, US

Alexandria, Virginia, US

• Responsible for the publishing of original INDs, NDAs, BLAs, ANDAs, and Master Files in both legacy and eCTD format under the direction of the Head of Electronic Publishing.
• Publishes maintenance amendments for existing electronic applications and performs QC of output.
• Transmits submissions to the FDA via the ESG for US Agent clients.
• Assists with software evaluations, SOP development, publishing training, formatting of Word documents, and drafting proposals for publishing projects.

Scottsdale, Arizona, US

• 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 performs pre-publishing activities in Adobe Acrobat Pro using TRS ToolBox to create internal navigation (i.e., bookmarks and hyperlinks).
• Assembled all client regulatory submissions [e.g., Investigational New Drug (IND) applications, protocol amendments, safety reports, annual reports, orphan drug designation requests, etc.] in both paper and eCTD format.
• Obtained a WebTrader production account for each client and uses a digital encryption certificate to submit through the FDA Electronic Submissions Gateway (ESG), archiving all receipts and acknowledgements in various.

Rostock, Mecklenburg-Vorpommern, DE

• Responsible for the management, publication, and validation 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 standard operating procedures (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.

Scottsdale, AZ, US

• Acted as primary liaison to coordinate the outsourcing of large eCTD submissions to Quintiles, including an original 505(b)(1) New Drug Application (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 Abbreviated New Drug Applications.
• Created eCopies to accompany paper submissions to the FDA Center for Devices and Radiological Health (CDRH) for medical device products under Investigational Device Exemption (IDE) and Premarket Approval (PMA).
• Collaborated with Creative Services Department to prepare promotional material for submission to the FDA Office of Prescription Drug Promotion (OPDP), averaging over 500 individual promotional pieces (in both paper and.
• 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.

Tempe, AZ, US

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.

St. Louis, Missouri, US

• Completed a paid six month co-op in the Technology Pipeline Solutions department as part of graduate coursework. Analyzed the needs of business users in order to identify solutions and defined requirements for software.
• Acquired proficiency in creating feature workflows and prototypes
• Conducted meetings with 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
• Drafted proposal to improve and track initial report development, incorporating risk assessment
• Spearheaded projects to improve the on-boarding process and auto-generation of test scenarios

Edwardsville, Illinois, US

Taught a biology dissection laboratory course to undergraduate students. Prepared pre-lab lectures, graded written lab assignments, gave weekly quizzes and proctored midterm exams. Responsible for 120 students.

US

• Completed a paid summer internship in the PCR department as part of undergraduate coursework. Offered a full-time position before moving to Illinois for graduate school.
• Pulled cervical smear specimens from cytology department for HPV testing
• Checked that specimens fulfilled QNS standards for subsequent high/low-risk processing
• Input specimen loads in computer system to be run on automated machines
• Answered calls from client services with questions about specific specimens

• During summer and winter breaks, researched lateral flow diagnostic test development. Also prepared production-quality immunoassays and buffers for Dengue IgG/IgM and Malaria Combo tests.
• Pipetted reagents at appropriate concentrations for striping nitrocellulose membrane
• Prepared antibody and antigen coated latex for spraying conjugate pads
• Used Excel and scanning software to record dipstick and cassette results in notebook
• Performed whole blood centrifugations, ELISAs, and serial dilutions for standard curves
• Attended weekly staff meetings and drafted SOPs for novel product development

Professional Science Master'S, Biotechnology Management

Bachelor Of Science, Molecular Bioscience & Biotechnology