[Janssen]Manager/Specialist, R&D Regulatory Affairs, Pre-clinical Dept, Toxicology Group
ü Evaluate pre-clinical toxicology data for clinical development and new drug application in Japan, discuss possible solutions to issues with global colleagues and clinical team, and propose the most appropriate solution (e.g. additional studies and/or documentation).
ü Prepare high-quality documents (e.g. briefing documents for PMDA consultation, common technical documents, responses to inquiries) about pre-clinical toxicology for clinical development and new drug application in Japan.
ü Establish good relationship to internal and external stakeholders as well as global colleagues.
üEducate and coach junior staff of the group (Manager)
• Conducting pre-clinical toxicological studies and having overall knowledge of pre-clinical safety
＜Skills and Capabilities＞
• Master of Science degree in medicine, pharmacology, biology, etc., or veterinarian
• Knowledge of guidelines related to pre-clinical safety
• Communication and leadership
• English (TOEIC ≥ 730)
・Person who can work in collaboration with relevant colleagues.
・Person who has experience in attending PMDA consultation.
・Person who has experience in clinical trials and preparing common technical documents (including responses to inquiries) about pre-clinical toxicology
Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).