Head of Legal&Compliance, Japan

Head of Legal and Compliance provides legal and compliance oversight, guidance and counseling to the Japan management team and the affiliate generally. The head drives a robust corporate culture that embraces integrity in our operations, consistent with the core values and principles of Biogen Code of Conduct.

This is a leadership role with country and global engagement. As a legal advisor and business partner to the affiliate team and the General Manager, the Head of Legal and Compliance works with the country to (1) implement a strategic and integrated compliance plan to continuously assess and enhance business processes while maintaining controls that are effective in managing identified risks and (2) provide timely legal advice and strategic business support. The role is expected to understand the complex landscape of global risk, reputational risk, local legal and regulatory risk, and local codes and ethics standards as it pertains to and impacts the activities conducted by the organization. 

The role reports separately into the Legal Department and the Corporate Compliance Department.  It is expected that the role will split his time evenly (50/50) between Legal and Compliance responsibilities.

Principal job duties outlined below may be modified or amended based on business needs and evolving compliance/legal requirements.

• Design and pull through of a compliance strategic plan consistent with the Global Corporate Compliance strategy, the Company’s business strategy and aligned with local needs and requirements.
• Design and maintain systems and records of management decisions, policies, processes, trainings, assessments, remediation plans, investigations, and enforcement actions in line with the Corporate Compliance handbook. 
• Provide advice and guidance to the business on compliance matters, including interactions and practices with health care professionals, government officials, health care institutions, patients and patient associations.
• Actively engage the leadership team in driving the tone from the top in integrity and championing a speak-up and transparent culture.
• Deliver training and communications to affiliate personnel on compliance topics.
• Design and maintain the architecture and excellence in effectiveness of policies, procedures, and controls through continuous monitoring of operational effectiveness, assessment and redesign or enhancement as needed.
• Conduct periodic risk assessments to identify and rank risks to help define prioritization of resources and activities.
• Execute comprehensive monitoring strategies informed by risk assessments and supported by data and technology to identify key risks and emerging trends for management reporting, including thorough root cause analysis. Contribute to the development of effective audit remediation plans.
• Ensure accountability through enforcement of relevant policies and applicable regulations.
• Ensure allegations of Compliance misconduct are timely reported.
• Actively follow compliance trends in the market and regulatory environment including in business practices and evolving compliance-related legislation and engage in local trade and compliance associations.
• Act as representative in the compliance group of the local industry association(s), ensuring compliance training and education is given to all employees (e.g. FCPA, COBC and other internal business conduct policies and rules) with escalation of issues to Head of Compliance – Internationa

Principal Legal Responsibilities (Japan):

• To be an active member of the Japan management committee(s). In this capacity the Head of Legal and Compliance Officer is expected to attend and to actively contribute to discussions and decisions at management committee meetings, providing prompt legal support, bringing good judgment and offering practical legal solutions to challenges facing the affiliates.
• Support the affiliate’s business operations / internal departments on all legal matters, with excellent drafting and communication skills. Provide legal support for commercial contract negotiations, public procurement, competition law, data privacy, etc.
• As directed, conduct internal investigations and maintain confidentiality of information.
• Work with Commercial, Market Access, Medical and Sales departments to provide strategic and effective legal support for launching new products and supporting marketed products.
• Review commercial and medical materials, as well as non-promotional disease state/scientific materials, as needed.
• Effectively select and manage relationship and expense with external counsel. Ensure that the best lawyers are engaged for specific matters.
• Act as representative in the legal group of the local industry association, ensuring legal training and education is given to all employees (e.g. FCPA, internal business conduct policies and rules) with escalation of issues to Chief Commerical & International Counsel.
• And other job duties that may be assigned.  May be modified at any time as business needs require.

Qualifications:

• Bachelor’s degree required (Japan Bar or International Legal Qualification (J.D or equivalent)
• 10+ years Legal experience with a least 5 years of Compliance experience (in house)
• Strong knowledge of Japan pharmaceutical regulations and codes (JPMA Code, APPI, FCPA, ABAC and other global requirements)
• Experience in the pharmaceutical, biotech, or other highly regulated industry (medical device)
• Native level Japanese and fluent business level English proficiency. Excellent communication and presentation skills and experience. 
• Experience in working in a multinational organization
• Experience with compliance program management, HCP/HCO engagements oversight and oversight of third-party intermediaries.
• Experience managing complex projects, including overseeing external vendors.
• Able to work at a high level of autonomy and has proven that he/she is able to competently lead a complex area of responsibility that requires significant experience and skilled judgment.
• Business-focused, collaborative and process oriented.
• Ability to manage ambiguity and provide pragmatic solutions whilst strengthening a strong compliance culture.