Career Category

Regulatory

Job Description

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)

• Over  5 NDA submissions and approvals in Japan (more preferred biologic experience)

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