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| 部署・役職名 | Clinical Affairs Specialist / Manager, Medical Affairs |
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| 仕事内容 |
Job Description About the Role: The Clinical Affairs Specialist will play a key role in supporting the development and implementation of clinical studies for our business units. This person will support the execution of study protocols and associated procedures by interacting with investigators and study sites, ensuring adherence to GCP principles and applicable regulations, and company SOPs. The Clinical Affairs Specialist will also support the creation of high－quality documentation, including study documents, essential documents, and regulatory filings. Job Description Summary: As a member of Medical Affairs, you will be responsible for the overall clinical development operations necessary for the introduction of various division products into Japan. This includes planning clinical strategies for product launch and appropriate use, as well as planning and conducting clinical research, clinical trials, and post－marketing surveillance （hereinafter referred to as ”research”）. Additionally, you will contribute to the introduction of products into Japan by preparing clinical parts of regulatory submission documents and verifying the reliability of data and submission－related materials using results obtained from overseas clinical trials. You will conduct research in compliance with relevant regulations, guidelines such as GCP （Good Clinical Practice） and GPSP （Good Post－Marketing Study Practice）, and internal procedures while collaborating with healthcare professionals, medical institutions, and other internal and external stakeholders. You will also be involved in the preparation, review, and management of related documents, including those necessary for regulatory submissions. Expected Duties: － Preparation and revision of research－related documents, including research implementation plans － Selection and contracting of participating medical institutions － Preparation and arrangement of research equipment － Understanding the research implementation status and conducting appropriate monitoring activities － Supporting data management and statistical analysis operations － Tracking and reporting safety information － Preparing and conducting reliability assurance activities － Preparing and managing related documents, including those necessary for regulatory submissions, annual reports, and re－examination applications － Collaborating and negotiating with relevant internal departments （domestic and overseas） － Coordinating and liaising with external stakeholders （healthcare professionals, regulatory authorities, academic societies, etc.） － Coordinating and managing external contractors （CROs, vendors, etc.） － Supporting the overall management of research－related projects （budget management, project management, etc.） |
| 労働条件 | No indoor smoking |
| 応募資格 |
【必須（MUST）】 － Bachelor's degree in a scientific field （or equivalent）－ Knowledge of GCP, GPSP, and GDP （Good Distribution Practice） － At least 3 years of practical experience in the pharmaceutical or medical device industry （including CROs） － Excellent communication skills （both written and verbal） － Business－level English skills or higher （TOEIC score of 730 or above） 【歓迎（WANT）】 － Master's degree in a scientific field or higher－ Experience in the field of cardiology/cardiovascular surgery （including vascular surgery） － Ability to manage multiple priorities simultaneously － Proficiency in Microsoft Office Suite － Experience in project management and/or personnel management |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/02/26 |
| 求人番号 | 4367307 |
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