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| This posting is managed by: | Cornerstone Recruitment Japan K.K. |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Primary Responsibilities Clinical Study Management: Lead the planning, execution, and oversight of various clinical studies—including those conducted before and after product launch—in collaboration with global teams or external partners. Regulatory Support: Contribute to regulatory documentation by preparing clinical study reports, international data submissions, clinical evaluation reports, technical files, and materials for regulatory consultations. Project Coordination: Ensure timely completion of clinical projects by identifying potential risks and applying effective mitigation strategies. Process Documentation: Develop and maintain standard operating procedures related to clinical affairs. Cross-functional Collaboration: Act as a subject matter expert, providing clinical insights across internal teams and strategic groups. Key Challenges Balancing numerous projects with different clinical scopes and regulatory requirements Maintaining high standards of quality and compliance across diverse activities Anticipating challenges to prevent delays and ensure project success |
| Company Info | A a British multinational medical technology company focused on repairing, regenerating, and replacing soft and hard tissue |
| Job Requirements |
Required: Bachelor’s degree in Life Sciences or a related discipline (Master’s degree is a plus) Experience in clinical development, preferably within the medical device, pharmaceutical, or biotech sectors Familiarity with GCP, ISO 14155, and relevant regulatory standards Strong skills in communication, organization, and project management Proficiency in Microsoft Office tools Preferred: Hands-on experience with clinical trial software such as Medidata or Veeva Vault Professional-level proficiency in English Background in orthopedics or wound care |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Fluent(JLPT Level 1 or N1) |
| Salary | Depends on experience |
| Holidays |
Core Competencies Ability to work independently and take initiative Flexibility and adaptability to shifting priorities Strong discipline and attention to detail Creative and analytical thinking Clear and effective communication skills |
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