In this role, you will be responsible for creating clinical trial protocols in Japanese based on the information received from clients regarding pharmaceuticals, medical devices, and regenerative medicine products. You will conduct gap analysis based on the information provided by clients, report on gap analysis and risk assessments regarding the client's development strategy and regulatory requirements in Japan. You will also plan meetings with the PMDA regarding the quality, non-clinical, and clinical tests necessary to start clinical trials, and prepare necessary documentation for submission to the PMDA. Additionally, you will respond to inquiries from the PMDA in coordination with clients. Working as part of a team, you will engage in some of the duties of a Clinical Trial Domestic Manager. The company offers services in monitoring, quality control (QC), consulting for pharmaceutical development and clinical trial planning and execution, regulatory affairs, data management, statistical analysis, medical writing, support for approval application work, and audit work. We boast a stable foundation combined with a challenging corporate culture, striving to not just meet but exceed standards of quality and deadlines through the procurement and development of excellent talent, maintaining compensation levels, and ongoing management innovation, which, in turn, establishes the Lincal brand and encourages repeat orders. Our revenue and operating profits have shown consistent growth.
The above information is a public job ad. This job ad is neither an offer nor a contract.
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