仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／生産管理、品質管理、施工管理、EHS、PMS |
|---|---|
| 業種 | 医療／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | 本部長/経営層レベル |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 | |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
Company Overview
◆グローバルランキング20位以内
◆医療用医薬品、アニマルヘルス、そしてバイオ医薬品受託製造の3つの事業分野に強み
◆循環器、呼吸器、中枢神経などの幅広い疾患領域での製品力
Job Description
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 partners and leading the interactions with Japanese regulatory agencies
Duties & Responsibilities:
• 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
Requirements
・獣医免許
・日本毒性病理学会認定(JSTP)
・日本獣医病理学専門家協会(JCVP)
・Required Capabilities (Skills, Experiences, Competencies)
・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
面接について
連絡先
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
RGFタレントソリューションズ株式会社
800 〜 1200 万円
