Job Description SummaryThe Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or
Job Description SummaryAs a BML, you will define the biomarker strategies and plans for a set of programs/projects, defined by asset or by indication, from early to later stage clinical development. You will also build external collaborations with
Job Description SummaryDrive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan. Job Description 職務内容 非臨床安全性担当者としてプロジェクトチームに参画しチームメンバーと協働し開発を推進する。 Globalメンバーの一員として，国内外の開発に非臨床安全性担当者として貢献する。 主な役割責任 早期化合物の安全性評価を行いチームへ適切に評価内容を伝える。 承認申請資料を作成し，当局からの照会回答を含む承認申請全般に責任をもつ。 治験届に関する資料作成を行い，当局からの照会対応を含む治験届業務全般に責任をもつ。 当局に対する相談について非臨床安全性担当者として責任をもつ
Job Description Summary-Responsible for key account management at a local level, usually managing a small team or managing specific account(s)/relationships. -Manage the business relationship and activities with key accounts in order to foster and extend the