Daniel Chang
Clinical Coordinator @ OtoNexus Medical Technologies
About
I am Daniel Chang, a recent graduate of the M.S. in Biomedical Regulatory Affairs at the University of Washington. I have experience across regulatory affairs, clinical affairs, and quality assurance, supporting regulatory submission and compliance activities.Highlights:1. I am a licensed pharmacist in Taiwan, with a professional background in pharmaceutical science and clinical pharmacy. 2. I have hands‑on experience supporting clinical regulatory activities in the recent two roles:- Clinical Coordinator at OtoNexus Medical Technologies (medical device clinical studies)- Research Assistant at the Cancer Vaccine Institute at UW Medicine (Phase II trials)3. My tenure as a Commercial Quality Specialist at AbbVie and Regulatory Affairs Intern at Eli Lilly sparked my passion for regulatory and quality affairs in the pharmaceutical industry.4. I am a tennis enthusiast! I have played tennis since I was in elementary school.
United States
Seattle
Pharmaceuticals
Clinical Site Management, Federal Regulations, Code of Federal Regulations, Clinical Research, Human Subjects Research, HIPPA, Good Clinical Practice (GCP), Institutional Review Board (IRB), Clinical Pharmacy, Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacotherapy, Pharmaceutical Sciences, Regulatory Science, Healthcare Marketing, Regulatory Affairs, Regulatory Documentation, Regulatory Submissions, Regulatory Operations
Experience
Clinical Coordinator
OtoNexus Medical Technologies
柏衛, WA
OtoNexus is an innovative medical device company that has developed the first hand-held device using breakthrough ultrasound technology to aid in the evaluation of middle ear infections. Responsibility: * Managed regulatory/IRB submissions and coordinated clinical site start‑up activities, ensuring compliance and shortening trial initiation timelines.
Regulatory Science Intern (Practicum Project)
Critical Path Institute (C-Path)
土桑, AZ
C‑Path is a nonprofit established in response to the US FDA’s Critical Path Initiative to streamline drug development and address key bottlenecks through scientific and regulatory innovation. Accomplishment: * Developed an orphan drug database for C-Path and supported regulatory strategy research for orphan drug development. * Researched the FDA Drug Development Tool (DDT) Qualification Program and analyzed the incorporation of a C-Path-developed patient-reported outcome (PRO) measure in clinical trials.
Research Assistant, Clinical Operations
UW Cancer Vaccine Institute
西雅圖, WA
UW Cancer Vaccine Institute is one of the largest academic labs in the US, leading the way in developing vaccines to treat and prevent cancer. Responsibility: * Supported study start-up and regulatory activities for multiple Phase 2 investigator-initiated clinical trials, including protocol and consent updates, preparation of regulatory documents, FDA IND amendment submissions, and IRB regulatory submissions.
Commercial Quality Specialist (Taiwan, Hong Kong)
AbbVie
Taiwan
AbbVie is a top 10 pharmaceutical company headquartered in North Chicago. The company specializes in immunology, oncology, neuroscience, eye care, and aesthetics. Accomplishment: * Managed lot release procedures for Botox, achieving a 100% on-time release rate. * Coordinated post-merger integration of 15+ products, including inventory inspection with local regulatory authorities. * Monitored cold chain shipments, ensuring compliance with Good Distribution Practice.
Regulatory Affairs Intern
Eli Lilly and Company
Taiwan
Eli Lilly and Company is an American pharmaceutical company focused on immunology, diabetes, oncology, and neurodegenerative diseases. Summary: * Compiled NDA binder and prepared CMC change submission, acquired experience with ICH Common Technical Document (CTD) format. * Renewed appearance data for 15+ types of oral tablets following TFDA requirements.
Pharmacist Intern
Lotung Poh-Ai Hospital
Taiwan
Summary: * Job Rotation: Oncology, drug information, ambulatory care, and critical care. Accomplishment: * Conducted comparative analysis of drug information tables for Herceptin and Trastuzumab biosimilars. * Summarized a randomized clinical trial to present a final report about treating rheumatic atrial fibrillation.
Summer Intern, Neuroscience Program
Academia Sinica, Taiwan
Taiwan
Academia Sinica is the national academy in Taiwan. Its mission is to pursue research, nurture academic talent, and issue policy advisors. Research topic: Effects of hydroxycamptothecin treatment on Tau-overexpressed cell model
Education
University of Washington
* Overall GPA 3.95/4.0
China Medical University
* Overall GPA 4.16/4.3 (Top 5%) * Three-time Dean's List honoree
University of Southern California
* Focus Area: Regulatory Science & Health Marketing
Daniel Chang's Contact Information
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