PK specialist

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MAIN FOCUS AND MISSION:

Leveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value

最新の薬物動態学及び薬力学に基づき、速度論的解析を駆使して、効率的な医薬品開発、承認申請及び化合物の価値最大化に貢献する。

ROLE & RESPONSIBILITIES:

・Evaluating PK/PD data related to international/domestic clinical and non-clinical studies according to ICH guidelines & regulatory notifications and regulatory interaction for development and registration of new medicinal products in Japan

ICHガイドライン/当局通知および当局交渉に準拠し、本邦での新医薬品開発および承認申請に向け、各種臨床試験および非臨床試験に関連するPK/PD関連データの評価を実施

・Authoring and reviewing clinical pharmacology-related documents in English/Japanese for New Drug Application (NDA) including CTD Module 1 [Package insert]and Module 2, Clinical Trial Notification related documents, briefing books for consultation meetings and those responses for h...