技能/経験

■What you’ll need (Required):Bachelor's Degree in in related field , 8 years experience of previous related experience required
• Business English proficiency and Native Japanese language skill
• Proven successful project management skills
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Extensive understanding of regulatory submissions, reporting, and audits• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment• Represents leadership on sections of projects within a specific area interfacing with project managers and clinical team
• Consult in project setting within specific sections
• Provides leadership to outsourcing partners on a task level

■What else we look for (Preferred):
• Experience working in a large manufacturing company
• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
• 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
Other: Certification in related discipline