Zuo Yen Lee

Section Editor Regulatory Matter

Zuo Yen is a proud life scientist-turned-medical writer since 2017. After completing her PhD in Biology and spending 10 years in scientific research and diagnostic industry, she decided to combine her scientific skills and knowledge with her passion for writing in pursuit of a career in medical writing. She has experience working on scientific publications and various types of clinical and regulatory documents including CSR, protocol, IB, ICF, and PSUR. Originally from Malaysia, she had lived in England and Switzerland, and currently lives in Taiwan where she works for the CRO Clinipace Research as a Senior Medical and Regulatory Writer. Zuo Yen is a keen traveler and nature lover who enjoys mountain trekking, hiking, and cycling.

Linkedin profile: www.linkedin.com/in/zuoyenlee

Zuoyen.lee@gmail.com 

Contributions

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue 3

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey…

Regulatory Matters - Volume 33, Issue 2

Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…

Regulatory Matters - Volume 32, Issue 4

Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…

Regulatory Matters - Volume 32, Issue 3

Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…

Regulatory Public Disclosure - Volume 32, Issue 3

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

Regulatory Matters - Volume 32, Issue 2

Abstract Training: Lessons in self-leadership Kathryn E. White (author), Zuo Yen Lee (section editor), Clre Chang (section editor) More often than not, freelancing means juggling between running a business and writing. Training may not be at the…

Regulatory Matters - Volume 32, Issue 1

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue 1

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…

Regulatory Matters - Volume 31, Issue 3

Contributors: Ri Xu (author) Zuo Yen Lee (section editor), Clare Chang (section editor) Hand and back muscle pain and how to avoid them: A regulatory writer's story Ri Xu Medical Writing. 2022;31(3)68-71. https://doi.org/10.56012/thzz1704

Regulatory Matters - Volume 31, Issue 2

Two years into the pandemic outbreak, our lives have changed one way or another. The pandemic not only has impacted our lifestyle, it might also have impacted our career at some level. We might find ourselves needing to venture out onto new paths,…

Big data in clinical research: Present and future - Volume 29, Issue 2

The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…

From bench to pen: Life as a new medical writer - Volume 28, Issue 1

In search of a career that would take advantage of their graduate-level skills, Clare Chang and Zuo Yen Lee found medical writing – a career path few PhD students consider. Within 6 months of graduating, with lots of effort and some luck, they found…

Getting Your Foot in the Door - Volume 26, Issue 2

In this June edition of GYFD, we are presenting the first part of a series on visa regulations and work permits related to internships in the EU. I would like to thank Van-Anh Dao for doing the legwork of researching the German requirements. We will…

Getting Your Foot in the Door - Volume 25, Issue 4

It’s been almost six months since the first EMWA Internship Forum (IF) in Munich. See what our IF team have to say about their first IF experience on pages 62-63. Even though we are already planning the next one for the spring meeting in Birmingham…