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神戸医薬研究所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 Pathologist BI20180626-2

掲載開始日 2018.06.26

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仕事内容

(Pathologist)

This position is responsible for non-clinical safety evaluations of multiple complex projects with toxicology/pathology knowledge in accordance to all applicable guidelines/regulations in close cooperation with BI partners and leading the interactions with Japanese regulatory agencies


Duties & Responsibilities:
・Safety assessment with high quality and within timeframe on NBI products under development and on market
・Close communication with BI 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 BI toxicologists /pathologists
・Contribution to BI global non-clinical safety activity in preparation of TS in CTD
・Preparation of TS for global CTD
・Collaboration with BI toxicologists/pathologists
・Harmonization with BI 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

詳細
勤務地 兵庫県神戸市
年収 900-1100万円
応募資格・スキル Requirements:

・獣医免許
・日本毒性病理学会認定(JSTP)
病理専門家http://www.japantoxpath.org/ja/diplomate/regulation/
・日本獣医病理学専門家協会(JCVP)
病理専門家http://jsvp.jp/jcvp/meetings/index.html

・Required Capabilities (Skills, Experiences, Competencies)
・BI Japan in-house coaching skill or equivalent (BI Japan 社内コーチングスキルまたは同等スキル)
・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
・Language
・Japanese:Native/Fluent
・English:Native/Fluent
・Special Work Experience
・>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
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