薬物動態安全性研究部非臨床安全性グループ マネージャー職/薬物動態研究 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 08月 23日

求人情報

薬物動態研究

求人管理No.011486

会社概要

薬物動態安全性研究部非臨床安全性グループ マネージャー職

外資製薬メーカーにて毒性/病理におけるマネージャーを担う

募集要項

・Safety assessment with high quality and within timeframe on products under development and on market
・Close communication with Germany and US
・Precise evaluation of toxicology data
・Play a role as an active R&D member of given projects
・Preparation of pertinent safety documents for J-NDA submission with high quality
・Preparation of CTD for J-submission
・Communication with toxicologists /pathologists
・Contribution to global non-clinical safety activity in preparation of TS in CTD
・Preparation of TS for global CTD
・Collaboration with toxicologists/pathologists
・Harmonization with standards
・Share the international workload
・Establish a reliable network with authorities and academia
・Establish a list of experts in toxicology in Japan
・Exchange information
・Align the functional activity worldwide
・Facilitate the international harmonization with NDSs in Biberach and Ridgefield
・Evaluation of toxicology package
・Toxicological evaluation of all in vitro /in vivo toxicity studies
・Pathology diagnostics and interpretation
・Evaluation of the pathology data from toxicity studies and carcinogenicity studies
・Monitor and evaluate modern technologies in the field of pathology
・Read slides and write a concise pathology report on non-GLP toxicity studies
・Responsible for the pathology software of the pathology data entry system

募集条件

  • ・Doctoral Degree eg. PhD or MD 博士修了
    ・Exceptional level of knowledge in the field of responsibility(Toxicology/Pathology)
    ・Negotiation skills in English / Japanese
    ・Knowledge on regulatory related laws and guidelines in drug development
    ・Strategic thinking
    ・Board certificate in Toxicologic Pathology / Veterinary Pathology
    ・Japanese:Native/Fluent
    ・English:Native/Fluent
    ・5 years experiences of working for international pharmaceutical R&D
    ・Proven performance record of working in the field of responsibility (>3 drug development projects)
    ・Good connection with academia and authorities

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 兵庫

転勤有無

  • 当面なし

給与

  • ご経験に応じての額となります。