Nancy Paz, MA

Nonclinical writer, medical editor, and quality control reviewer skilled in authoring and editing regulatory documents for global submissions for both marketed products and drug development candidates. - Lead nonclinical writer of the following regulatory submission types: Investigational New Drug (IND), Marketing Authorization Application (MAA), Development Safety Update Report (DSUR), annual reports, investigator brochures, briefing documents, requests for information, and informed consent forms. This list is not the complete list of authored submissions. -Aligned messaging and ensured regulatory compliance with SMEs from the following functions: regulatory operations, pharmacology, toxicology, pharmacovigilance, DMPK, and clinical. - Performed quality control and editorial review with timely resolution of over 100 regulatory submissions, nonclinical study reports and journal articles ensuring accuracy and adherence to the company style guidelines. Quality spelling and grammar checks performed to AMA standards. - Led 3 training sessions in quality control data integrity and technical editing of Module 2 and Module 4 documents. Post-training, demonstrably improved copyediting and the global quality of documents accelerating IND timelines using Veeva RIM and Adobe Acrobat. - Spearheaded the development of department regulatory submissions tracker, facilitating technical support and tracking of over 400 regulatory submissions improving departmental efficiency. - Performed technical and scientific reviews of dossiers prior to electronic Common Technical Document (eCTD) publication. - Authored quality control standard operating procedures upholding industry standards.

In vitro assay development scientist supporting Takeda as a consultant via Eurofins and Randstad. Developed expertise in several rare disease areas: Gaucher disease, Fabry disease, and Phenylketonuria. - Recognized for project management of complex, large sample in vivo studies. Acknowledged for successful scheduling of high quality data collection leading to process improvements.

Quantitative immunohistochemistry scientist skilled in cochlear microdissection, histology, confocal microscopy, and image analysis of 3D light microscopy images. Determined the ability of multiple gene therapy drug targets to rescue hair cell loss to various hearing insults. - Developed proprietary trade secret MATLAB script for the rapid frequency mapping of three-dimensional cochlear images.

Motivated team-oriented pharmacologist who via in vitro, in vivo, and novel quantitative histochemistry defined aspects of the mechanism of action of ONIVYDE. These MOA studies supported the 2.6 modules for ONIVYDE (nanoliposomal irinotecan). - Contributed scientific findings to the nonclinical pharmacology modules of the ONYVIDE IND (US) and ONYVIDE Clinical Trial Application (CTA) (EU). ONIVYDE was approved in the US in 2015 and in the EU in 2016 for use after gemcitabine-based therapy. - Actively managed sponsored research agreements and other academic collaborations with an immunooncology research focus demonstrating problem solving and ability to work independently.

Assay development lead for in vitro, in vivo testing, and the validation of oligomeric antibodies against the epidermal growth factor receptor (EGFR) for various oncology drug targets. Developed and transferred to the quality assurance (QA) team a novel preclinical potency assay to measure the biological potency of human alpha-fetoprotein according to regulatory requirements. Acknowledged for communication skills and attention to detail.

Developed and clinically assessed multiple in vivo models of chronic inflammation for validation of an IKK-beta inhibitor via PET (positron emission tomography) and NIRF (near infrared fluorescence imaging). Supported Millennium/Bayer life sciences collaboration in the cardiovascular space to identify novel atherosclerosis drug targets. Comfortable with Microsoft office suite - presentations in powerpoint, data analysis in excel.

MA Pharmacology