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Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
Janssen pharmaceutical K.K. (JPKK) is recruiting for a Japan project risk management Specialist, located in Tokyo. R&D organization of Janssen Pharmaceutical K.K. (JJRD) is one of Janssen R&D. JJRD is developing new drugs targeting the Japanese market and not only join in global clinical trial, but also have some Japan studies for Japan NDA. Furthermore, JJRD takes lead Japan original indication projects. This position is a Japan project/study "End to End" risk management role who will drive enhanced quality risk manage project/study risk on GCP and safety. Key Responsibilities: Performs Quality reviews of key documents developed for use in clinical trials and in preparation for submission to Japan regulatory health authorities from JPKK. Provide input into IQP (Integrated Quality Plan) for Japan-indication projects/JPKK study and develop/implement effective and efficient risk mitigation plans. Assist in Japan registration of clinical trial which is regulatory requirements and maintain integrity. For quality issues on JJRD project, lead and/or support early detection, report and resolution, of the issue. Assist in Japan submission/registration readiness each study and hold and lead stage gate review for Japan NDA. Collaborate with Regulatory Compliance to lead CIT (Core Inspection Team) (or support CIT if other person has the CIT Lead role) for PMDA inspection and to support inspection readiness for other HA inspection. In the case other Japan pharma company who is J&J business partner will submit NDA with including Janssen study, support RC/QP&S TA. Further, take CAPA QL role for observations from PMDA inspection. Demonstrate quality analytics data, internal and external factors and contextualized key quality insights to provide quality consultancy to primary partners. Influence the regulatory environment in Japan by assisting senior RM to analysis the gap between regulation and real/global level values on key regulations in Japan region. Qualifications Qualifications Education: Bachelor of Science (BSc) degree in a life science, natural science or business is required. An advanced degree (MD, PhD, MSc, or PharmD) is helpful Experience and Skills: Required: Minimum of 5 years of previous Pharmaceutical proven experience in R&D and/or quality and compliance area, or equivalent level of expertise and the experience. Detailed knowledge of the drug development process, good knowledge of related international/local regulations, GCP/GPSP/GVP/GCLP regulations and other study related regulation/industry-level self-regulation. Self-motivated and flexible with the ability to work optimally in a fast-paced change in the business environment and problem-solving is required. Ability to handle risk. Logical thinking and problem-solving skills. Good conflict handling/resolution and negotiation skills such as able to build win-win situations with internal and external partners. Proficiency in Japanese and English (both oral and written). *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). Primary Location Japan-Tokyo-To-Chiyoda- Organization Janssen Pharmaceutical K.K. (7195) Job Function R&D Requisition ID 2206004023W
Child care benefits
Short term disability