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Position Purpose: T he Clinical C o m pance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligned compliance support to study teams focusing on adherence to procedural/regulatory requirements and Corrective and Preventive Action ( CAPA) coordination to ensure inspection readiness. Reporting Relationships: T h i s p o s i t i on r ep o r t s t o t he Senior CCO Manager and w il l ha v e g l obal r espons i b ili t... more ->
?: ?GxP? ?PV? ?PSMF? ?PV?PV? ?/? ? ?/? ? ? ? ? ? ?/? ? ? ?/'sME/Leads? ? ?/? ?: ?/?(?);?/?(?)?3? ?5? ?3? ?/?PV? ?/?GxP?IT? ? ? ?CAPA'sOP? GxP? ? Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and... more ->
Responsibilities: To Perform routine quality related activities (product release, deviation and internal complaint handling, CAPA, change control, GMP oversight and product recall) in compliance with global quality policies and local regulatory requirements To Collaborate with internal stakeholders; Global Quality Assurance: to introduce global policy standards, Global Manufacturing Sites: to solve quality related issues and make ensure stable supply without significant quality/regulatory issues, Regulatory Affairs: to establish and implement the submission strategy, Logistics and Supply... more ->
The Biostatistician in Japan provides statistical contribution to a clinical development program, including e-data and CDISC for submission to PMDA. The Biostatistician implements statistical strategies for clinical trials and regulatory submissions, and is accountable for statistical deliverables. The position is to collaborate with all therapeutic areas. More specifically: 1 - Support development of components (CSR, CTD, CDISC, e-Data, DSUR) for submission to PMDA and interact with global and local team 2 - Perform quality control of the key e-data and CDISC deliverables 3 - Support... more ->