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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 ->
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 ->