Naoko Watabe/Iwamae

Working remotely / self-employed

Naoko Watabe/Iwamae

Working remotely / self-employed

Malaysia

Naoko Watabe/Iwamae

Working remotely / self-employed

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Summary ・4 years’ experience in Investigational Products Quality Assurance (Japan) ・10 months’ experience as Quality Control for Clinical Trials (Japan) ・6years’ experience in clinical development as a Clinical Research Associate(CRA) / CRA L

未来

この先やってみたいこと

未来

I would like to be more involved in Clinical Operations in Japan and Asia.

2018年8月
-
現在

Working remotely

3 years

self-employed
現在

2018年8月 -

現在

・Translation, Sales, Writer, Research, Tape transcription(English) ・Input Scientific evidence into Healthcare media(articles), Build Logic ・Audit/Assessment Support ・Expand Network for Patient Recruitment Business in Asia (HK, TW, SG, MY, TH, PH etc) and USA/EU ・Management for Project of Patient Recruitment executed in Asia ・Quality Check for

2017年9月
-
2018年7月

Orinental Wellcare Group (Malaysia)

1 year

Business Development

2017年9月 - 2018年7月

・On-site Feasibility review for M&A project of Medical institute in Malaysia ・Project Management of Online Medical Platform for Healthcare professional in Malaysia ・AI Doctor project (preparing/editing Medical Data and Learning materials) ・Prepared English Medicine Data Set for Drug information system ・Wrote Newsletters for Patients

2016年8月
-
2017年7月

Samurai Incubate, Inc (Outsourcing agreement)

1 year

writer

2016年8月 - 2017年7月

・Investigate overseas Start-up companies and prepare/write web contents for Media of Samurai Incubate, “SAKIGAKE” ・Be in charge of Start-up companies in Healthcare/Medical/Agriculture ・Close Media, “SAKIGAKE”, in Jul 2017

2015年7月
-
2016年5月

CMIC Asia Pacific (Malaysia)

1 year

Clinical Project Leader (VN, TH, MY, SG)

2015年7月 - 2016年5月

- Executed Asian Trial (Phase 3) - SDV(Source Data Verification) Visits in Malaysia and Thailand with CRAs - Gave the compliance training (including Good Documentation Practice) to Clinical Research Associates and Trial Site staff

1995年4月
-
2014年8月

Novo Nordisk

20 years

MR(sales), CRA(Monitor), CRA Leader, Senior CRA, QC(Clinical), IP-GMP-QA

1995年4月 - 2014年8月

・4 years’ experience in Investigational Products Quality Assurance (Japan) - Conducted all Batch release of Investigational products from the factories and Qualification Test of Cold Storage room - Conducted Vender Audits as a trainee Lead-Auditor - Participated GMP Audit (held by Novo Nordisk, Denmark)

1995年3月

京都工芸繊維大学 kyoto institute of technology

Microbial Chemistry

1995年3月

応用生物学科卒業(農学士) 微生物化学教室(小田耕平教授)にてGABA産生乳酸菌について研究 家庭の事情で、奨学金・学費免除、アルバイト(パン屋、家庭教師)などを利用して大学生活を賄いました

1991年3月

兵庫県立姫路西高校 Himeji Nishi High School

1991年3月


スキルと特徴

Leadership

0

Team Building

0

Highly motivated to learn

0

Excel

0

Writing

0

Awards and Certifications

ICH GCP Training Certificate

2021年7月

AWS Security Fundamentals

2021年7月


言語

日本語 - ネイティブ, 英語 - 日常会話