臨床開発における品質及び信頼性確保活動

---

Job details

Company overview

We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.

Responsibilities

臨床開発メンバーと協働し治験の品質確保を積極的に推進するとともに、治験全体の品質を担保するためにOversight・指導を行うことで円滑な治験実施と治験の質向上に寄与する。臨床試験実施中の品質担保に関わるタスク・課題について臨床開発メンバーをサポートすることで解決を図る。 (1)Quality Manegement              (2)Risk Management(3)SOP Management

Requirements

必須条件:以下いずれかのQuality Management経験（Globalプロセスならなお良し）

• Quality Control（CAPA Management, Process Management）
• Risk Management
• SOP Management
• TMF management

歓迎条件:

• 臨床開発業務の経験
• 臨床開発モニター経験
• 他部門／他社との協働、交渉経験

Salary

6.55 - 9.16 million yen

Location

Tokyo