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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 ->
If you need assistance during the recruiting process due to a disability, please reach out to our Recruiting Accommodations Team through the Accommodation Request form . This form is used only by individuals with disabilities who require assistance or adjustments in applying and interviewing for a job. This form is not for inquiring about a position or the status of an application. Senior Area Manager The Senior Area Manager is responsible for leading a team that is responsible for the account management, strategy implementation, and planning within an assigned market geography. As a Senior... more ->
Purpose Maximize the value of the products in charge to the company (top line and bottom line) and also to the patient who need our products and service as a leader of the TA, like a president of the brand(s). Motivate and vitalize the people who work on the brand in all departments by setting vision and mission of the team. Responsibility Set a Vision and Goal Responsible for setting reasonably ambitious sales and share target for annual cycle and long-range of the TA/Brand. Build sales forecast with logic by putting reasonably aggressive assumptions Develop winning strategy and tactical... more ->
Position Purpose: The Senior Medical Writer is responsible for planning, preparing, and managing medical writing projects as well as creating and reviewing documents in some instances. The incumbent is responsible for the creation and maintenance of document/presentation templates, and is responsible for the assembly and quality control review of medical writing projects related to clinical development as well as regulatory submissions. Reporting Relationships: This role reports to the Head of Medical Writing Japan Main Responsibilities and Accountabilities: 1 Responsible for planning and... more ->
If you need assistance during the recruiting process due to a disability, please reach out to our Recruiting Accommodations Team through the Accommodation Request form . This form is used only by individuals with disabilities who require assistance or adjustments in applying and interviewing for a job. This form is not for inquiring about a position or the status of an application. The Manager, Account Management is responsible for leading a team that is responsible for the account management, strategy implementation, and planning within an assigned market geography. As a Manager, Account... 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 ->