[HCC] Director of Business Transaction Support [IM]

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Job Function: Legal & Compliance

Job Sub Function: Health Care Compliance

Job Category:People Leader

All Job Posting Locations:Chiyoda, Tokyo, Japan

Job Description:

SUMMARY: Implements J&J IM Japan’s promotional activity compliance program and ensures that its promotional activities are in compliance with Japanese laws, regulations and industry codes, including the Pharmaceutical and Medical Devices Act, regulations on advertisements, the Ministry of Health Labour and Welfare Guidelines on Promotional Information Provision Activities, and the Japan Pharmaceutical Manufacturers’ Association Code of Practice, while also ensuring compliance with J&J policies and procedures including the International Health Care Business Integrity Guide and other relevant guidance documents. This position reports to the Health Care Compliance Officer, J&J IM Japan and is based in Tokyo, Japan. 

PROFILE: 

• Leads a team of compliance professionals to ensure that J&J IM Japan’s promotional and scientific/educational activities comply with applicable laws, regulations, industry codes, and internal policies
• Requires strong communication, organizational, analytical and people management skills
• Ability to work effectively with local and global/regional colleagues, as well as internal business stakeholders and external stakeholders including government authorities, industry associations, business partners and promotional activity experts
• Background may include Medical Affairs, Research & Development, Regulatory, as well as Compliance, with strong medical or scientific background (desired but not required)
• Proven track record of delivering results, a self-starter with ability to manage complexities and ambiguities
• The position is a member of the J&J IM Japan HCC Leadership Team, responsible for organizational management including budget and talent development.
• Proven track record as a people manager, with experience in leading, developing, and coaching team members

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Ensures promotional activities at J&J IM Japan are in compliance with relevant laws, guidelines and the JPMA Code of Practice, by setting up and maintaining an appropriate promotional materials review process at J&J IM Japan, and by monitoring its promotional activities including by its services providers and business partners

• Serve as the HCC point of contact and strategic partner to Business Units encompassing a variety of promotional activities such as speaker program, sponsorship and FFS.
• Serve as the HCC point of contact and strategic partner to Medical Affairs encompassing a variety of activities, including disease awareness, patient support, scientific information dissemination, patient organizations, and investigator initiated studies/joint studies
• Acts as JPMA Code Supervisor for J&J IM Japan
• Chairs Business Compliance Committee (BCC), a subcommittee of J&J IM Japan’s Compliance and Audit Committee (CAC)
• Administers the Review and Supervisory Committee
• Ensures proactive communications with key internal and external stakeholders on J&J IM Japan’s promotional activities, taking a solution-oriented approach
• Leads and works collaboratively with the wider HCC team including colleagues outside Japan and in other sectors, as well as internal stakeholders such as the Business Units, Medical Affairs, Legal, Regulatory, Communications & Public Affairs, Integrated Market Access, and Commercial Excellence
• Supports the HCCO as a member of HCC LT member 

EDUCATION and EXPERIENCE: 

• Bachelor’s degree required; an advanced degree in a scientific discipline is preferred but not required
• Minimum of 10 years of experience in compliance, legal, or other business-related functions, preferably within the pharmaceutical industry, including exposure to Medical Affairs, Regulatory Affairs, and Compliance
• Knowledge of laws, regulations and industry standards for Japan
• People management experience strongly desired
• Project management experience, especially in multicultural settings, preferred.

SKILLS and ABILITIES: 

• Independent, principle-based, and objective thinker, able to advance ideas and influence others
• Ability to manage conflict in an open and constructive manner. Demonstrated strong organizational, interpersonal and communication skills
• Ability to work effectively in ambiguous and evolving situations Excels at developing and maintaining effective partnerships and working relationships with key stakeholders at all levels of organization based on an understanding of their concerns, needs and motivations.
• Ability to make and stand by difficult decisions
• Strong results orientation and a solution-oriented mindset Strong champion of diversity, equity, and inclusion principles
• Fluency in English, both written and spoken, is required High level of integrity and strong ethical values

Required Skills:

Preferred Skills:Audit Management, Compliance Management, Compliance Risk, Consulting, Continuous Improvement, Corporate Governance, Cross-Functional Collaboration, Developing Others, Healthcare Industry, Health Care Regulation, Inclusive Leadership, Leadership, Legal Services, Medical Compliance, Organizing, Program Management, Regulatory Compliance, Risk Management