プロフィール詳細

プロジェクトを作成

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Dr. Vera Bin San C.に依頼

France

Regulatory Medical Writer with 10+ year of Scientific Publication Experience | Eye on Biostatistics Details | Rapid QC service

プロフィール概要

Are you looking for a medical writer who can prepare regulatory submissions for an investigational medicinal product (IMP), e.g. clinical research protocol (CRP) and clinical study report (CSR) in a compliant, on time, and on-budget manner? On a timeline? I can rapidly perform data QC, extract literature from PubMed/Google Scholar, and transform any drafted document into a professional standard. I have full-time working experience as a medical writer and regulatory affairs in the pharmaceutical industry. My role supports the rapid and compliant preparation of a variety of regulatory documents (CSR, CSP, IB, DSUR), and submits applicable core documents to National Competent Authorities. I can adapt my writing style to fit Agency guidelines, writing styles, and formatting templates, e.g. Training slide deck (PPT file) and regulatory affairs documents (WORD, PDF, eCTD dossiers). With 6+ years of scientific publication background and certified knowledge of Good Clinical Practice (GCP), I can understand benifit/risk factors and biostatistics of clinical projects, and have an efficient workflow that delivers complex research writing projects. My academic background and academic writing style have satisfied the reviews by many Key Opinion Leaders (KOLs), saving time and cost of finalizing regulatory documents. Before working as regulatory affairs medical writer, I have extensive experience in writing conducting a literature review, preparing scientific data for peer-reviewed publications, and submitting research proposals to national funding agencies, and writing press releases for communicating the science to the public audience. With my international experiences, I naturally connect well with clients from all ethnic backgrounds, and I am an independent worker and a trusted team player who can speak English, French, Mandarin, and Cantonese. Please message me to propose any writing projects, enjoy our first 1-h technical meeting for free!

専門分野

• ★ Medical Device Regulatory Writing
• ★ Clinical Trial Protocol Writing
• ★ Clinical Study Reports
• ☆ Image Processing
• ☆ Food Science
• ☆ Medical Devices
• ☆ Clinical Trials
• ☆ COVID-19
• ☆ Clinical Laboratory Science
• ☆ Public Health
• ☆ Scientific Animation & Illustration

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

職務経験

Postdoctoral Researcher

Ifremer Centre de Bretagne

11月 2018 - 4月 2020

Postdoctoral Research Associate

Clemson University

2月 2015 - 10月 2018

Postdoctoral Fellow

University of Hong Kong

1月 2014 - 9月 2014

学歴

PhD (Biological Sciences)

University of Hong Kong

9月 2009 - 10月 2013

Bachelor of Sciences (First Class Hon)

University of Hong Kong

9月 2006 - 6月 2009

認定資格

• Good Clinical Practice (GCP) Training

  The National Institute on Drug Abuse (NIDA)

  1月 2021 - 現在

• Principles of Clinical Pharmacology

  The National Institutes of Health (NIH)

  https://ocrtraining.cit.nih.gov/

  8月 2020 - 現在

• Introduction to the Principles and Practice of Clinical Research

  The National Institutes of Health (NIH)

  8月 2020 - 現在

出版物

JOURNAL ARTICLE

Chan, Vera BS and Toyofuku, Takashi and Wetzel, George and Saraf, Laxmikant and Thiyagarajan, Vengatesen and Mount, Andrew S(2017). Characterization of Calcification Events Using Live Optical and Electron Microscopy Techniques in a Marine Tubeworm. JoVE (Journal of Visualized Experiments). (120). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString e55164--e55164.

Li, Chaoyi and Meng, Yuan and He, Chong and Chan, Vera BS and Yao, Haimin and Thiyagarajan, V(2016). Mechanical robustness of the calcareous tubeworm Hydroides elegans: warming mitigates the adverse effects of ocean acidification. Biofouling. 32. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 191--204. Taylor \& Francis

Chan, Vera Bin San and Vinn, Olev and Li, Chaoyi and Lu, Xingwen and Kudryavtsev, Anatoliy B and Schopf, J William and Shih, Kaimin and Zhang, Tong and Thiyagarajan, Vengatesen(2015). Evidence of compositional and ultrastructural shifts during the development of calcareous tubes in the biofouling tubeworm, Hydroides elegans. Journal of structural biology. 189. (3). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 230--237. Elsevier

Chan, Vera and Toyofuku, Takashi and Wetzel, George and Saraf, Laxmikant and Thiyagarajan, Vengatesen and Mount, Andrew S(2015). Direct deposition of crystalline aragonite in the controlled biomineralization of the calcareous tubeworm. Frontiers in Marine Science. 2. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 97. Frontiers

Ko, Ginger WK and Dineshram, R and Campanati, Camilla and Chan, Vera BS and Havenhand, Jon and Thiyagarajan, Vengatesen(2014). Interactive effects of ocean acidification, elevated temperature, and reduced salinity on early-life stages of the pacific oyster. Environmental science & technology. 48. (17). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 10079--10088. ACS Publications

Milazzo, Marco and Rodolfo-Metalpa, Riccardo and San Chan, Vera Bin and Fine, Maoz and Alessi, Cinzia and Thiyagarajan, Vengatesen and Hall-Spencer, Jason M and Chemello, Renato(2014). Ocean acidification impairs vermetid reef recruitment. Scientific Reports. 4. Nature Publishing Group

Li, Chaoyi and Chan, Vera BS and He, Chong and Meng, Yuan and Yao, Haimin and Shih, Kaimin and Thiyagarajan, Vengatesen(2014). Weakening mechanisms of the serpulid tube in a high-CO2 world. Environmental science & technology. 48. (24). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 14158--14167. ACS Publications

Lane, Ackley C and Mukherjee, Joy and Chan, Vera BS and Thiyagarajan, Vengatesen(2013). Decreased pH does not alter metamorphosis but compromises juvenile calcification of the tube worm Hydroides elegans. Marine biology. 160. (8). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1983--1993. Springer

Chan, Vera BS and Thiyagarajan, Vengatesen and Lu, Xing Wen and Zhang, Tong and Shih, Kaimin(2013). Temperature dependent effects of elevated CO2 on shell composition and mechanical properties of Hydroides elegans: insights from a multiple stressor experiment. PloS one. 8. (11). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString e78945. Public Library of Science

Ginger, Ko WK and Vera, Chan BS and Dineshram, R and Dennis, Choi KS and Adela, Li J and Yu, Ziniu and Thiyagarajan, Vengatesen(2013). Larval and post-larval stages of Pacific oyster (Crassostrea gigas) are resistant to elevated CO2. PLoS One. 8. (5). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString e64147. Public Library of Science

San Chan, Vera Bin and Li, Chaoyi and Lane, Ackley Charles and Wang, Yanchun and Lu, Xingwen and Shih, Kaimin and Zhang, Tong and Thiyagarajan, Vengatesen(2012). CO2-driven ocean acidification alters and weakens integrity of the calcareous tubes produced by the serpulid tubeworm, Hydroides elegans. PLoS One. 7. (8). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString e42718. Public Library of Science