Profile Details

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USD 90 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Vera Bin San C.

France

USD 90 /hr

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

Profile Summary

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!

Subject Matter Expertise

• ★ 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

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing, Newswriting

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

Work Experience

Postdoctoral Researcher

Ifremer Centre de Bretagne

November 2018 - April 2020

Postdoctoral Research Associate

Clemson University

February 2015 - October 2018

Postdoctoral Fellow

University of Hong Kong

January 2014 - September 2014

Education

PhD (Biological Sciences)

University of Hong Kong

September 2009 - October 2013

Bachelor of Sciences (First Class Hon)

University of Hong Kong

September 2006 - June 2009

Certifications

• Good Clinical Practice (GCP) Training

  The National Institute on Drug Abuse (NIDA)

  January 2021 - Present

• Principles of Clinical Pharmacology

  The National Institutes of Health (NIH)

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

  August 2020 - Present

• Introduction to the Principles and Practice of Clinical Research

  The National Institutes of Health (NIH)

  August 2020 - Present

Publications

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). p. 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). p. 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). p. 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. p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. e42718. Public Library of Science