| 職務内容 |
Develop accurate and effective Clinical, Scientific, and Regulatory documents to drive strategic initiatives
【Primary Duties】
・Liaise with Project Manager, RACA Strategy and Regulatory Affairs to discuss and develop the strategies toward PMDA consultation and regulatory application.
・Develop and evaluate clinical study protocols, manage the process to obtain, evaluate, and resolve cross-functional input for document finalization.
・Develop and plan clinical activities to drive strategic initiatives in collaboration with team members with accountability for successful completion of all deliverables.
・Develop clinical documents for PMDA regulatory application including previous human experience summaries, literature reviews, and interim and final clinical study reports for the assigned projects/devices.
・Provide expertise in the formulation of medical writing deliverables for assigned clinical studies serving as the primary project contact, negotiating deliverable timelines, and resolving project-related issues
・Other related duties as assigned
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| 応募要件 |
【Education and Experience】
EDUCATION: Bachelor's degree in related field or equivalent; 5+ years of experience in regulatory documentation for clinical trials required
【Other Skills】
・Expertise in MS Office Suite including Adobe, ability to operate general office equipment
・Excellent written and verbal communication skills, including negotiation and relationship management skills
・Excellent problem solving and critical thinking skills
・Excellent ability to read, write, and speak English
・Strong knowledge and understanding of global and Japanese medical device regulatory guidelines
・Ability to manage confidential information with care
・Ability to manage competing priorities in a fast-paced environment
・Ability to work in a team environment, including interdepartmental teams and key contacts representing the organization on projects.
・Comply with all company rules and requirements (e.g., pandemic preparedness, environmental health and safety regulations) and take appropriate control measures to prevent injury to self and others, as well as to protect the environment and prevent pollution within your sphere of influence and control.
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