- Contribute to global clinical studies to support regulatory submissions and PMS
- Contribute to the Development and Approval of Lifechanging Medical Devices
- Pioneering global medical device company with expertise in orthopedics, surgery, interventional solutions and vision care
- Responsibilities may include the following and other duties may be assigned.
- Oversees, designs, plans and develops clinical evaluation research studies.
- Prepares and authors protocols and patient record forms.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
- May be responsible for clinical supply operations, site and vendor selection.
- People working within region/country may also have the responsibilities that include:
Represents company in a clinical research respective within the country / region and also collects feedback from local customers and authorities.
- Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
- Drives local evidence dissemination awareness.
- Expertise in ICH, GCP and related regulations
- High level of communication skills
- Business level English (reading, writing, speaking)
- Fluent level of Japanese
- Opportunity to contribute to clinical development of medical devices