Mgr, Clinical Science (Tokyo)
- Tokyo, Japan
Provide leadership and clinical expertise in support of new product clinical development and /or marketed product idication expansion.
- Plan clinical affairs projects and activities with accountability for successful completion within scope of project deliverables
- Provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, investigator's brochure, sponsor ICF, and reports/data presentations/publications.
- Prepare documentation for regulatory submissions required in Japan and other counties (if requested), and communicate with PMDA from the perspective of clinical science.
- Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/registries from initiation through completion.
- Identify and evaluate clinical affairs process improvements and/or course correction/course alignment opportunities.
- Other incidental duties
Education and Experience:
- Bachelor's Degree in scientific or related field with 8 years previous clinical experience in cardio vascular area
- Master's Degree or equivalent in a related discipline
- 8 years experience of medical writing of medical device
- Proven expertise in both Microsoft Office Suite, including advanced Excel
- Experience with CTMS and electronic document management systems a definite plus
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Ability to perform in a diverse cross-functional team environment and have ability to converse effectively with all levels of employees, management, and customers
- Comprehensive record of delivering research information which adds value to management decision making process
- Demonstrated ability to understand and comply with all current applicable regulations, ICH Good Clinical Practice(GCP), ISO 14155 and Company operating procedures, processes, policies, and tasks
- Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
- Extensive understanding of cross-disciplinary and knowledge of the clinical profession
- 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
- Ability to represent leadership on sections of projects within a specific area interfacing with project managers and cross-functional teams
- Ability to consult in project setting
- Adhere to all EHS rules and requirements 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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