Job summary
| Job category | Professional (Consulting / Finance / Real Estate / Professional Services)／Professional Services (Health Care / Welfare / Education / Instruction) |
|---|---|
| Industry | Health Care／ Other Health Care |
| Employment type | Uncategorized |
| Position level | Other |
| Number of openings | 1 |
| Desired entry time | - |
| Required language skill |
English （Business） Japanese （Fluent） |
| Foreign language competence | - |
| Working hours | Others |
| Welfares / Leave systems | |
| Assistance in visa application | - |
| Number of foreign employees | - |
Work details
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
About interview
Liaison
Study Design & Data Science Manager
RGF HR Agent
1200 〜 1600 ten thousand JPY
