＊This role requires native level Japanese and Business English＊
Role & Responsibility:
- Manage a large team RA/QA and Medical Affairs
- Collaborate with Regulatory member both in Local and Global, and with all of member related to New product introduction process
- Support local clinical studies for registration purpose as well as for higher clinical recognition
- Support to obtain registration approval/certification
- Collaborate with pharmaceutical industry for companion diagnostics for novel drugs
- As Head of Medical, Quality and Regulatory Affairs, collaborate with our Global Headquarters and cooperate with domestic Key Opinion Leaders (KOLs) to maximize the clinical value of our innovative new products in Japan. We will establish a system and carry out domestic clinical research as needed.
- In addition, you will be responsible for a series of processes for consulting and negotiating with the authorities and obtaining regulatory approval and insurance coverage.
- As for products after launch, the main task is to work with teachers of academic societies and on-site clinicians to educate the significance of measurement in on-site medical care and to spread it widely.
- In addition, you will be responsible for ensuring the quality of a wide range of products in cooperation with our Global headquarters and relevant authorities.
- Japanese level: Native
- English level: Business
- People Management experience
- One of the following:
- Faculty status in the medical school and / or important role in the medical / academic community
- Work experience with MHLW, general agencies and other authorities
- Work experience at a pharmaceutical / medical device company
Ideal knowledge and skills / qualifications
- MD education and licensing
- Clinical trial design and medical insights
- Medical communication channel experience
- Stakeholder involvement experience
- Advanced marketing concepts and market access
- Strategic thinking