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Location: Tokyo, Kanto
Salary: Open
Employment Type: Permanent
Languages: English > Business Level, Japanese > Native
Sub-industry: Pharmaceuticals
Function: Healthcare R & D, Healthcare R & D

Company Overview

Global Pharma Maker

Job Description

・ Produce protocol concepts in collaboration with stakeholders
・ Comply with industry and company rules
・ Budget management of the project in charge
・ Leading and passing examination work in company RC
・ Acquire approval in response to inquiries from PMDA
・ Affiliate Study Design
・ Affiliate Study consultation support ・ Method proposal
・ Protocol creation with other stakeholders
・ Get approval of the created Protocol

Requirements

・ Knowledge of work related to pharmacy law
・ Knowledge of fair competition rules
・ Knowledge of laws and regulations related to pharmaceutical application
・ Work knowledge related to GPSP ministerial ordinance
・ Business knowledge related to GVP ministerial ordinance
・ Knowledge of clinical trial related laws and guidelines
・ Basic knowledge and correct understanding of statistics, experimental design
methods and epidemiological methods
・ Responsible for the medical research implementation plan as a research designer

Additional Information


Probation Period: 1
Smoking Conditions: y
Overtime: 1
Social Insurance: y
Holidays: 1
Working Hours: 9:00 AM - 6:00 PM
Lunch Break: 12:00 PM - 1:00 PM

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