Description

SUMMARY:

Implements Janssen 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 in compliant 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, Janssen Japan and is based in Tokyo, Japan. 

PROFILE: 

·       Manages a team of compliance experts to ensure compliance with relevant laws, regulations, industry codes, and internal policy, of Janssen Japan’s promotional and scientific/educational activities

·       Requires strong communication, organizational, analytical and people 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 Janssen Japan HCC Leadership Team, responsible for organizational management including budget and talent development.

·       Proven track record as people manager in managing and developing people

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

·       Ensures promotional activities at Janssen 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 Janssen Japan, and by monitoring its promotional activities including by its services providers and business partners

·       Be the HCC point of contact and strategic partner with 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 Janssen Japan

·       Chairs the Promotional Activity Review Committee, a subcommittee of Janssen Japan’s Compliance and Audit Committee (CAC), and the Compliance Consultation Meeting

·       Administrates the Review and Supervisory Committee

·       Ensures proactive communications with key internal and external stakeholders on Janssen 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

·       Contributes to HCC team building as an HCC LT member

EDUCATION and EXPERIENCE:  

·       Minimum of BA/BS required; any other advanced degree in science (preferred but not required)

·       Minimum of 10 years of compliance, legal or business-related experience preferably in the pharmaceutical industry, including 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.

Qualifications

EDUCATION and EXPERIENCE:  

·       Minimum of BA/BS required; any other advanced degree in science (preferred but not required)

·       Minimum of 10 years of compliance, legal or business-related experience preferably in the pharmaceutical industry, including 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

·       Manage conflicts in an open and constructive manner

·       Demonstrated strong organizational, interpersonal and communication skills

·       Deals well with ambiguity

·       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 drive for results and solution orientated

·       Strong champion of diversity, equity, and inclusion principles

·       Fluent in English (reading, writing, verbal) required

·       High level of integrity with good ethical core values

·        Fluent in Japanese strongly preferred, but not required

COMMENTS:   This position description is an outline of the major recurring responsibilities of the job.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).