Join a leading global MedTech innovator as a Medical Affairs Manager in Tokyo and play a pivotal role in advancing patient care through the introduction of innovative medical products. You will lead clinical strategy, oversee compliant study execution, and drive regulatory approval processes in Japan, collaborating with internal teams and external stakeholders to shape the future of healthcare.
Key Responsibilities
- Plan, execute, and report clinical studies (trials, research, PMS) in compliance with GCP, GPSP, and GDP standards
- Develop and implement Japan-focused clinical strategies for new product launches
- Manage and submit clinical documentation for regulatory filings ensuring data accuracy and integrity
- Partner with cross-functional teams and engage with KOLs, healthcare professionals, and regulatory bodies
- Lead vendor management for CROs and other clinical research partners
- Oversee clinical project timelines, budgets, and deliverables
- Mentor and support professional growth within the Medical Affairs team
Required Skills and Qualifications
Experience:
- Bachelor's degree in a scientific field or equivalent
- 5+ years of experience in the pharmaceutical or medical device industry, including CRO collaboration
- In-depth knowledge of GCP, GPSP, and GDP regulations
- Strong communication skills and stakeholder engagement experience
Language Requirements
- Japanese: Native level
- English: Intermediate to Business level (TOEIC 800+ or equivalent)
Preferred Skills & Qualifications
- Master's degree or higher in a life sciences discipline
- Background in cardiovascular or vascular surgery-related medicine
- Proven leadership in taking clinical projects through to trial success or regulatory approval
About the Company
Our client is a U.S.-based global medical technology company dedicated to improving healthcare safety and access worldwide. The company delivers advanced biotechnology and medical devices, supporting both clinical innovation and operational efficiency. With a strong presence across multiple regions, the organization is committed to driving patient outcomes, medical advancement, and cost-effective care.
Why You'll Love Working Here
- Influence the introduction of cutting-edge healthcare solutions in Japan
- Collaborate with international experts in a global MedTech setting
- Strong career advancement path in a listed multinational company
- Flexible work style with flextime and generous paid leave options
- Weekends off, seasonal holidays, and comprehensive social benefits
Don't Miss Out - Apply Now!
