Cathi Lynn Puglisi

Cathi Lynn Puglisi has extensive experience in the field of medical writing and documentation. Starting in 2011, they worked as a Technical Information Writer and Services Coordinator at Coperion until an unknown date in 2012. Cathi Lynn then joined Par Pharmaceutical as an Associate Director, where they were responsible for creating, editing, and distributing drug monographs to comply with regulatory standards. Additionally, they served as the FDA 'war-room' coordinator and liaison for unannounced inspections.

In 2016, Puglisi became the Quality Manager and Documentation Specialist at Halo Pharmaceutical, Inc., where they ensured compliance with quality standards. Following this, they worked at Insmed Incorporated as the Manager of Documentation and Clinical Quality Control/Editing/Writing from December 2018 to September 2019.

In 2017, Puglisi worked as a Clinical Narrative Medical Writer at Celgene, specializing in creating clinical narratives. From November 2019 to July 2020, they served as a Medical Writer III at Merck, focusing on global scientific content and global medical affairs.

Puglisi joined Bayer Pharmaceuticals in July 2020 as an Expert Clinical Medical Writing Specialist until an unknown date in 2022. Cathi Lynn then moved to Aquestive Therapeutics in October 2021, where they worked as a Regulatory Medical Writer responsible for creating and writing various clinical study reports and FDA responses.

Most recently, Puglisi started working at ONO PHARMA USA, INC. in January 2023 as a Senior Medical Writer in Clinical Development, specializing in oncology, neuroscience, and rare diseases. In this role, they perform medical writing activities for key clinical regulatory documents and submissions, including study protocols and clinical study reports (CSRs). Cathi Lynn is also responsible for writing and quality control of regulatory submissions for investigational new drugs (INDs) and new drug applications (NDAs).

Cathi Lynn Puglisi has pursued a comprehensive education, focusing on various subjects related to human behavior, counseling, and psychology. Cathi Lynn completed their Bachelor's Degree in Biological Sciences / Pre-Medicine from Rutgers University–New Brunswick between 1986 and 1991. After that, they enrolled in Capella University, where they obtained a Master of Science (MS) degree in a part-time program covering General Human Behavior, Clinical Mental Health Counseling, and Psychology from 2011 to 2019. Currently, they are attending Capella University once again, this time pursuing a Doctorate degree in part-time Psychopharmacology from 2020 to 2024.

Cathi Lynn Puglisi has also obtained several certifications throughout their professional journey. In 1993, they achieved the certification from the American Society of Clinical Pathology (ASCP). Later, they acquired certifications from the American Medical Writers Association (AMWA) in January 2008, the NJ Professional QC Association (NJPQCA) in August 2009, and Chi Sigma Iota in February 2011.