| 職務内容 |
Ensure X's clinical study device documentation provides a valid source of device traceability and accountability data for regulatory submissions, reporting, and audits.
【Key Responsibilities】
・Lead in the investigation of all discrepancies by applying clinical protocol knowledge and develop processes to minimize possibility of recurrence
・Lead in assessing current process, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
・Conduct in house and site (if applicable) reviews of associated documentation and lead in internal and Japan agency audits to ensure documents are compliant with Good Documentation Practices, Edwards internal SOPs, and Japan regulations
・Resolve basic remote queries closures within electronic databases
・Analyze local clinical trial results and develop report for inclusion in the submission to PMDA
・Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Japan regulations and X's requirements
・Provide coaching and training to lower level employees
・Other incidental duties
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| 応募要件 |
【Education and Experience】
Bachelor's Degree or equivalent in in related field, 5 years years experience of previous experience working with regulatory documentation for clinical studies Required
【Additional Skills】
・Proven expertise in MS Office Suite, including Adobe, and ability to operate general office machinery
・Excellent written and verbal communication skills including negotiating and relationship management skills
・Excellent problem-solving and critical thinking skills
・Excellent ability to read, write and speak English
・Full knowledge and understanding of X's policies, procedures, and global and Japan medical device regulatory guidelines relevant to clinical protocols
・Full understanding of regulatory submissions, reporting, and audits
・Excellent computer skills in usage of Microsoft Office Suite, including Word, Excel, and PowerPoint
・Excellent written and verbal communications skills
・Advanced problem-solving and organizational skills
・Ability to manage confidential information with discretion
・Strict attention to detail
・Ability to interact professionally with all organizational levels
・Ability to manage competing priorities in a fast paced environment
・Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
・Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
・Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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