About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
BeOne is seeking a compliance professional to help lead the Healthcare Compliance programs in Japan (and potentially other markets in region). Reporting to Head of Compliance, JAPAC, this is an excellent opportunity to serve as the primary interface for Japan commercial organizations to support the launch of new BeOne therapies while at the same time contributing to the Company’s geographic expansion in those markets. The position will contribute to the development and implementation of organizational strategies, policies and practices, and work with the Japan Leadership team to integrate appropriate healthcare, corporate and other compliance controls to guide the Company’s operations. The position will be based in Japan.
Responsibilities:
Support the continued development of the Japan Healthcare Compliance Program in line with the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance), applicable industry codes (including but not limited to, JPMA code, JFTC etc.) and best practices.
Proactively identify legal and regulatory issues, industry trends, industry codes and practices applicable to Healthcare Compliance; and advise on the adoption of new, or revision of existing, policies and procedures to ensure the continued effectiveness of the Company’s Healthcare Compliance Program.
Assess the potential impact of Commercial, Medical, Clinical Development and other initiatives to the Company’s Healthcare Compliance Program and support the design of policies, procedures, processes and/or systems, including but not limited to HCP fair market value methodology and third party risk management, to manage identified risk areas.
Establish policies, procedures and systems to foster compliance with healthcare fraud and abuse, privacy, and transparency reporting obligations, as well as applicable industry codes in the region.
Develop and monitor the execution of a comprehensive compliance training program for Japan employees and designated third parties on applicable healthcare compliance policies, laws and regulations, including any new developments or updates that may impact the Healthcare Compliance Program.
Provide compliance leadership and oversight for review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.
Collaborate with other functions on the design and execution of internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary.
Partner with internal (e.g., Legal and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for the conduct and resolution of potential compliance investigations, including the…