Our company is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it’s not just what we do, it’s who we are. We are 75,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.Your role:Exciting opportunity to lead the team working on Cardiac and Endovascular registration projects for Image-guided Therapy, which includes novel technologies integrated by therapeutic devices and visualization systems.
業務内容:
Lead the Japan Team and all clinical studies and evidence development projects that the team is responsible for to proceed with the plan
Lead developing local clinical evidence development strategy and strategic discussion with the local RA team and other related stakeholders, including Business Unit, R&D, and Market Access & Reimbursement to accelerate projects and fast serve patients
Proactively identify risks within clinical evaluation strategies, plans, products and propose alternate approaches
Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed
Stay informed of new regulations and technologies relevant to endovascular therapeutics
Plan and execute clinical evidence development, GCP compliance review of foreign operated clinical trials, and PMS study as a condition of approval according to the regulations and aligned with local business needs
Manage interactions with MHLW/PMDA/KTLs and maintain a productive working relationship
Manage CRO services to ensure meeting with business needs and operational policies
Review and approve clinical documentation according to the GCP/GPSP requirements
Oversee clinical administration activities
応募資格:
+10 years’ experience in clinical operation including medical device
Experience in the Study Manager role in medical device clinical studies and GCP compliance inspections by PMDA
Maintains extensive knowledge of the PMD act, GCP ordinance, GPSP ordinance, ICH guidelines, and ISO13485
Experience or working knowledge of EVT or any cardiovascular therapeutic medical devices
+3 years' experience in people management
Self-motivated and able to prioritize handling multiple tasks/responsibilities
Capable of thinking critically, logically, and strategically
