Nonclinical Scientist

Company Overview
■世界ランキング上位に入る米国製薬メーカー
■成長性のある多くの新薬パイプライン保有
■福利厚生充実、安定して働ける環境

Job Description
・ Contribute to the development plan/strategy as a member of JEDT/JFDT on behalf of nonclinical function team and provide nonclinical input obtained from the counterpart (PCO, DSE) and other functions such as JEAT, Global Regulatory Team (GRT) and Early Development Team (EDT).
・ Prepare the nonclinical-related parts of regulatory documents required for the development from start of clinical study to JNDA filing and thereafter; Investigators Brochure (IB) for CTN, Common Technical Document (CTD) for JNDA, and Product Summary, Interview Form, Proper Use Guide and Educational Materials for launch and marketing.
・ Make presentation or discuss with the PMDA reviewer and IRB expert about nonclinical matter, and respond with scientifically justified responses to nonclinical-related queries in PMDA consultation, CTN and JNDA filing with the necessary support of global counterpart.
・ Investigate nonclinical data package of global early development projects to ensure the required studies are available for starting clinical development (CTN) and filing (JNDA) in Japan. If the data were not satisfy the requirement, report to supervisor and draw up a solution plan.
・ Provide information on early development candidates and evaluation to JEAT to contribute for establishing early development plan in Japan.
・ Retrieve and evaluate the latest information on drug seeds and scientific findings in Japan, and provide the updated information to the global organization in charge (BD, Research Collaboration).
・Coach the junior staff in the nonclinical-related work for development of products in Japan from early development to JNDA filing and thereafter

Requirements
・ Comprehensive knowledge/skills of either the field of pharmacodynamics, pharmacokinetics and/or toxicology.
・ Current knowledge of molecular biology.
・ Comprehensive and precise knowledge of ICH (International Conference of Harmonisation) guidelines and Japanese guidelines for nonclinical studies of drugs.
・ Knowledge of new drug development process and procedure.
・ Skill of scientific literature preparation and QC/QA checking.
・ Good understanding of project management and ability to manage time lines.
・ Experience of planning and conducting nonclinical studies in either fields and preparation and review of a study report.
・ Experience of CTN and filing related documents (IB and CTD).
・ Experience of communicating with the PMDA reviewer and IRB expert
・ Experience of launching more than one drug product as JFDT member from CTN to filing.
・Good communication skills in both Japanese and English (OPA score 5.5 or higher).

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