(MedTech) Medical Affairs, Clinical Affairs, Staff

Overview:
This position is accountable for leading in the development of clinical evidence generation and dissemination strategies across assigned projects.
Main responsibilities and duties:
• Lead to evidence generation strategy with collaboration relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs, HEMA, etc) as a clinical member.
• Responsible for delivery of assigned clinical programs leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP)
• Responsible for team's interface and collaboration with key opinion leaders, investigators, IRB's/ECs, regulatory agencies, societies, associations, etc;
• Lead in clinical scientific discussions with PMDA to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including sponsor regulatory inspections.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
必須

• 3 years of CRA (臨床開発) experience (医療機器または医薬品)
• Business level English and Japanese (oral and written communication)
• Project planning and managing skills
• Demonstrates influence, negotiation, and conflict resolution skills.

尚可

• Team leadership experience