15178 Legal & Compliance Manager
・This position will report to the Head of Legal Japan (APAC) and have the responsibility to handle day -to-day operations. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are highly valued.
【Key Duties and Responsibilities】
・Provide day-to-day advice and counsel to the various business functions across the company.
・Draft and negotiate a range of contracts including non-disclosure, speaker, grant, vendor,
consulting, ad board, clinical trial, manufacturing, research & development, academic research, call-center partnerships and/or other collaborations.
・Interpret company policies and develop risk mitigation strategies relating to conducting clinical trials, funding for scientific research, data sharing, patient recruitment, antikickback rules, informed consent requirements and privacy protections.
・Support Business Development with strategic transactions and initiatives by providing due
diligence support, drafting, and reviewing term sheets and definitive agreements, as well as coordinating input from the appropriate stakeholders.
・Ensure internal compliance and review regulations.
・Participate in multifunctional committee reviews of press releases, promotional and medical materials, and publications in oversight of commercialization activities.
・Proactively collaborate with IP counsel to advise on intellectual property due diligence in potential mergers, acquisitions, licenses, and other strategic initiatives that involve IP.
・Assist in the drafting, updating, and implementation of internal company guidelines and training materials regarding contracting processes and ethics.
・Communicate and work closely external legal firm.
・10+ years of experience practicing law in global pharmaceutical / Medical device industry
including practices regarding Japanese Drug and Medical device act and Fair transaction guidelines.
・Experience of launching pharmaceutical, biotech or medical device products in Japan.
・Experience effectively developing and implementing strategy with outside counsel as
・Must have the ability to provide business-oriented solutions to complex problems.
・Excellent ability to communicate oral/ writing, and to draft legal documents in both Japanese and English strongly preferred