Position overview
As a strategic business partner, this individual contributes to the company’s growth and success locally and globally from a legal and compliance perspective. This individual is required to enable business by analyzing the situation logically, assessing risk and benefit, and working closely and actively with various functions across the company rather than being conservative and behaving like a judge. This individual reports to the Head of Legal & Compliance Div.
Key Duties and Responsibilities
- Collaborate with business functions to provide sound legal and compliance advice that aligns with the company’s strategic goals and supports overall growth.
- Draft, review, and negotiate a wide range of contracts both in Japanese and English.
- Participate in multifunctional committee reviews of press releases, promotional materials, and publications in oversight of commercialization activities.
- Plan and restructure compliance program, including organizing a global compliance committee, establishing an event management system, and monitoring general regulations such as privacy areas.
- Establish, revise, or repeal internal rules/policies/SOPs, including rules of approval authority.
- Lead initiatives to ensure company-wide understanding and compliance with relevant laws and regulations, including conducting internal training sessions.
- Provide sound advice on Intellectual Property(IP) area and operate IP management by collaborating with global patent team and business functions.
- Operate contract lifecycle management system and maintain its data accuracy.
- Operate services related to the Company Act.
- Streamline business processes in legal and compliance areas.
- Maintain or update content on the intranet.
- Support other affiliates; such as Taiwan and India as well as the Headquarter.
Desired Education, Skills and Experience
- Must have 5+ years of experience in legal and compliance roles within the pharmaceutical/medical device industry. Experience in reviewing promotional materials from a legal and compliance perspective aligned with industry regulations is strongly preferred.
- Demonstrated the ability to provide business-oriented solutions to complex problems.
- Excellent written and verbal communication skills with the ability to clearly explain complex legal or compliance matters to non-legal/compliance professionals in both Japanese and English are strongly preferred.
- Experience in Intellectual Property Management, especially patent management, is a strong plus.
- Demonstrated ability to work independently and proactively with minimal supervision.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- A high level of proficiency with IT tools and systems, including experience with legal tech solutions and compliance software.
- A bachelor’s degree in law or JD is required. An Attorney’s license or patent attorney license in Japan is a plus.
What We Do
Rakuten Medical, Inc. is a global clinical stage biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its AlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. The company has locations in 5 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit www.rakuten-med.com.
