募集要項
- 募集背景
- A leading producer of biomedical laboratory equipment is looking to hire a Regulatory Clinical Affairs Specialist with clinical trials experience. In this role you will be in constant communication with doctors, professors, and PMDA/MHLW officers regarding clinical trials of in vitro diagnostic (IVD) products.
- 仕事内容
-
A leading producer of biomedical laboratory equipment is looking to hire a Regulatory Clinical Affairs Specialist with clinical trials experience.Responsibilities:
* Generate a protocol for clinical trials of in vitro diagnostic (IVD) Class III registrations
* Coordinate clinical sites, commercial laboratories, and occasionally CRO/SMO to smoothly conduct trials
* Implement the clinical trial process into clinical sites and commercial laboratories, and monitor the status of ongoing studies
* Discuss the academic knowledge and clinical utilities for product registration with clinical investigators
* Generate clinical trial reports for IVD filing documents including data analysis
* Apply for new reimbursement requests for Class III registered products
Requirements:
* Advanced degree in Pharmaceutical Sciences or Molecular Biology preferred
* Experience conducting clinical trials for IVD, MD, or drug Class III registrations
* Experience and/or knowledge of IVD reagents and/or molecular biology is a plus
* Experience communicating with doctors, professors, and PMDA/MHLW officers is also a plus
* Business level English proficiency
- 応募資格
-
- 必須
- Experience conducting clinical trials for IVD, MD, or drug Class III registrations
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY9,000,000.00 - JPY14,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇