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) according to industry best practices.• 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 using cloud-based publishing software docuBridge for submission to the FDA Center for Drug Evaluation and Research (CDER) Division of Oncology.• 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 document management systems (i.e., ShareFile and SharePoint).

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 workshops held by the Regulatory Affairs Professionals Society (RAPS).

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 (ANDAs), authored in Octagon’s StartingPoint templates.• 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) applications.• 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 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).

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 member. Included bi-weekly lectures and a weekly four-hour laboratory session. Prepared powerpoint presentations, comprehensive exams, lab exercises and practicals, homework assignments, and all other course materials.

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 development. Offered an extension for the month of December.• 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