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Manager of Pathology/Toxicology

年収:800万 ~ 1200万

ヘッドハンター案件

部署・役職名 Manager of Pathology/Toxicology
職種
業種
勤務地
仕事内容 Job description
Responsible for non-clinical safety evaluations of multiple complex projects with in-depth knowledge of toxicologic pathology in accordance with all applicable guidelines/regulations in close cooperation with other the company's sites
Leading interactions with Japanese regulatory agency
Contributing to global safety-related activities

Duties & Responsibilities
Precise evaluation of toxicology/pathology data (in vitro and in vivo) and support of clinical trials/ investigators in Japan

Active member in project teams
Preparation and peer review of high quality regulatory submission documents

Preparation of briefing documents and questions for PMDA consultation (inquiries, written/F2F)

Reading tissue slides and write concise pathology reports of non-GLP/GLP toxicity studies using the pathology data entry system

Assessments for occupational exposure limits (OELs) and permitted daily exposure (PDE) values for (pre-)development compounds and approved API and advice to employees

Close interaction with peer functions
Follow-up on current science and technology in toxicology/pathology and establish a network of experts in Japan
応募資格

【必須(MUST)】

Required Skills
Doctoral Degree (PhD or MD博士修了) with a minimum of 5 years’ experience within pharmaceutical R&D
Proven performance record in the field of responsibility (ideally >3 drug development projects)
Board certificate in Toxicologic Pathology / Veterinary Pathology (JSTP, JCVP or equivalent) or
Board certificate in Toxicology (JSOT or equivalent)
Exceptional level of knowledge in the field of responsibility (Toxicology/Pathology)
Knowledge of GLP and regulatory compliance
Good connection with academia and authorities
Excellent communication skills in Japanese and good skills in English, both verbal and written
Able to effectively work in an international and cross-functional environment
Strategic thinking and proven problem solving ability

更新日 2020/05/26
求人番号 1380887

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