淼 仝
Medical communication scientist @ AstraZeneca
About
Around 5 years of experience working as medical writer focusing on regulatory documents including CSR, IB, protocol, ICF, and other CTD M2 or M5 documents for both IND/CTA and NDA submission.
China
Shanghai
Pharmaceuticals
流行病学, 定量研究, 生物统计学, 统计数据分析, 翻译, 英语专业八级, literature review, 数据分析, 医学写作, 临床试验, Google Cloud Platform (GCP), 法规要求
Experience

Medical Writer
上海 浦东新区
Participated in several projects: CSRs: 5 whole CSRs writing with several CSR reviews and QCs, and abundant narrative writings; TA-oncology; Protocols: 4 whole protocols with several protocol amendments and revisions; TAs-oncology, endocrinology and urology; · ICFs: 4 ICFs; TAs- oncology and metabolic disorders; IB: 1 IB; TA-oncology; Briefing book: 1 briefing book; TA-oncology; Manuscript: 1 publication; TA-oncology; Clinical overview: 2 clinical overviews; TA-oncology; IND submissions: supported 2 IND submissions; NDA submission: participated in 2 NDA package preparation including writing 1 bridging report, 2 clinical summaries of efficacy, 2 clinical summaries of safety, and other supporting clinical documents; TA-oncology and psychiatry; Translation and translation validation: large amounts of translation and translation validation work related with different TAs. Responsible for managing format guideline for several departments. Developed a style guide for medical writing team; Developed a format management tool for several function teams in dMed. Offer supports for technical issues related with document format and style guide. Responsible for quotation management for medial writing team. Supported in the development of quotation templates for medical writing team; Responsible for drafting quotations for different medical writing projects. Responsible for management of internal and external trainings for CS&MA team members. Offer specific onboard training for new CS&MA members and support on-the-job training for team members.

Intern/Volenteer
斐济
● Study on the Weather Effects on Dengue and Dengue Surveillance System in Suva, Fiji ● Assist in a student program studying the relationship of density of Aedes aegypti mosquito and dengue incidence in Suva, Fiji ● Assisting in a program improving the local disease reporting system ● Keeping minutes of meetings ●Thesis: Study on the Weather Effects on Dengue and Dengue Surveillance System in Fiji

Research Assistant
中国 北京市区
● Research assistant (Intern); Participating in a book chapter writing, Volume 5 Chapter 10 Stroke, Disease Control Proprieties in Developing Countries 3rd edition (DCP3) ● Research assistant (Intern); Participating in the research on the feasibility of verbal autopsy based on smartphone in northern rural China ● Publication: A feasibility study on using smartphones to conduct short-version verbal autopsies in rural China ● Personal assistant (Intern); Being the temporary personal assistant of the deputy director of George Institute, China and helping arranging some daily affairs
Education

Biomedical English
2012-2013 Scholarship for outstanding medical students of PUHSC, Third Class 2011-2012 Scholarship for outstanding medical students of PUHSC, Third Class 2011-2012 Outstanding Individual in Summer Social Practice, Institute of Medical Humanities, PUHSC, Third Class 2011-2012 Excellent Summer Social Practice, Institute of Medical Humanities, PUHSC, Third Class 2011-2012 Excellent Summer Social Practice, Institute of Medical Humanities, PUHSC, First Class 2011-2012 Excellent Summer Social Practice Outcome, Beijing, China 2010-2011 Outstanding Individual in Summer Social Practice, Institute of Medical Humanity, PUHSC 2010-2011 Excellent Summer Social Practice, Institute of Medical Humanities, PUHSC, Third Class 2010-2011 English Drama Contest of Medical Humanities, Institute of Medical Humanity, PUHSC, First Class 2009-2010 Computer Application Design Contest, PKU, Third Class,
淼 仝's Contact Information
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