**Job Summary** • Execute local preclinical documentation (Investigators Brochure for J-CTN, Briefing Document for PMDA consultation, and CTD preparation for J-NDA) and RTQs from Japan Health Authorities with Global Translational Science and Preclinical Development and manage outside service providers • Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen **Key Activities** + Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB for J-CTN + Input Japan-specific requirements for preclinical development to global members as a local expert + Prepare and respond to preclinical questions for CTD and IB from PMDA with global members + Interact with Japanese healthcare providers (PMDA, academic organizations, and National Institute of Health Science) to obtain acceptability of preclinical data for J-NDA of innovative medicines + Interact with Key Opinion Leaders and/or Principle Investigators to convey preclinical knowledge of candidates (more of a focus area in Japan than in the west) **Knowledge and Skills** + Knowledge of preclinical science (toxicology, pharmacology, and/or drug metabolism) + Knowledge for documentation (preclinical writing) and the quality of IB and CTD + Knowledge of Preclinical regulations/guidelines (including GLP and ICH) in Japan + Preclinical (toxicology, pharmacology, and/or drug metabolism) experiences in research lab + Working in matrix environments as One Team + Communication skills + Negotiation skills to Japan Health Authorities + English conversation, read, and writing + Computers: Microsoft Outlook/ Word/ Excel/Power Point **Education & Experience (Basic)** + Master or Doctorate degree and 10 years of directly related experience + Over total 5 years experiences with preclinical pharmacology, toxicology and/or drug metabolism for supporting CTN and NDA submission in Japan + Over 5 years experiences in pharmaceutical industry **Experience (Preferred)** + Over5 NDA submissions and approvals in Japan (more preferred biologic experience)