求人・転職情報
1件中の1〜1件を表示
大手外資製薬メーカー
仕事内容
担当する臨床試験の全プロセスにおいて、規制当局の要件や社内基準を遵守し、患者の安全と権利を守るための品質管理を戦略的にリードします。
求める経験 / スキル
■Education(minimum/desirable):
Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.
■Languages:
Fluency in English (oral and written)
■Experience/Professional requirement:
１．+7 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
２．Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
３．Ability to work independently and in a global/matrix environment.
４．3 or more years’ experience in managing projects.
５．Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
６．Strong skills in GCP, quality and/or clinical development.
７．Strong interpersonal, communication, negotiation, and problem solving skills.
Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.
■Languages:
Fluency in English (oral and written)
■Experience/Professional requirement:
１．+7 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
２．Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
３．Ability to work independently and in a global/matrix environment.
４．3 or more years’ experience in managing projects.
５．Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
６．Strong skills in GCP, quality and/or clinical development.
７．Strong interpersonal, communication, negotiation, and problem solving skills.
勤務地
東京都
想定年収
800 万円 ~ 1,600 万円
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