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Toranomon (NPKK Head Office), Japan
Onsite
Job Description Summary
Drive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan.
Job Description
職務内容
主な役割責任
必須要件
望ましい要件
Major Accountabilities
· Authoring responsible parts of J-NDAs, response to PMDA and all of the other activities for submission if necessary.
· Assessment of pharmacological and/or toxicological profiles of early projects to contribute to Japan development strategy.
· Roles as JPT/JST members
· Support of TM clinical studies as pharmacologists and/or toxicologists including protocol/ICF review, IB review and interaction with HAs.
· Seeking opportunity of proposals about new development programs/ indications
· Participate/support initiatives, task-forces, and cross-functional activities in Dev./NPKK.
· Quality management responsibility
- Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
- 100% timely delivery of all training requirements including compliance
Key Performance Indicators
· Appropriate quality and timing of NDA and post NDA activities
· Appropriate quality and timing of pharmacological and/or toxicological profiling/evaluation of early projects
· Appropriate quality and timing of study supports
Background
Education: MSc or PhD in life sciences (Pharmacology, toxicology, Pharmaceutics, other specific sciences), DVM/MD or equivalent professional experience.
· Experience/Professional requirement:
· Taking education or possessing knowledge of basic medicine, such as physiology, pharmacology, toxicology, anatomy/histology, molecular biology, etc.
· For mid-carrier employee, experience in pharmacology, toxicology or relevant field of the pharmaceutical Industry, CRO, academia, etc.
English Skill:
Appropriate skills of English (read/write and oral)
Benefits and Rewards
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Commitment to Diversity and Inclusion
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Accessibility and Accommodation
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Additional Information
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Skills Desired
Animal Models, Bioinformatics, Collaboration, Data Analysis, Ethics, Problem Solving, Regulatory Compliance, Toxicology