Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Legal & ComplianceJob Sub Function:
Health Care ComplianceJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda-ku, Tokyo, Japan, JP007 Tokyo J&J HeadquarterJob Description:
SUMMARY:
This position, as a member of Johnson & Johnson’s global, cross-sector Health Care Compliance organization—and more specifically of the Health Care Compliance team supporting the Innovative Medicine Sector business in Japan—entails ensuring Innovative Medicine Japan’s business practices and activities, in particular its promotional and educational materials, are carried out in compliance with applicable J&J’s internal policy and guidelines, local laws, regulations and industry codes, such as the JPMA codes and the MHLW Guidelines on Promotional Activities, as well as anti-corruption laws including the Foreign Corrupt Practices Act. Reporting directly to the Group Manager supporting certain therapeutic areas of focus for Innovative Medicine Japan, and part of the larger team, Business Transaction Support, headed by an HCC Director (who reports to the Health Care Compliance Officer for Innovative Medicine Japan) who are trusted advisors providing day-to-day support to all of Innovative Medicine Japan’s therapeutic areas to ensure that their interactions with, and scientific and promotional information provided to, health care professionals and government officials are consistent with J&J policy, laws, regulations and industry codes, this position is responsible, first and foremost, for reviewing promotional and educational materials in the assigned therapeutic areas that go through the company’s copy review process, providing feedback on and risks associated with the materials to the applicant, so that Innovative Medicine Japan’s promotional and educational information dissemination activities meet internal and external expectations. This position is located in Tokyo, Japan.
PROFILE:
- Second-level reviewer and approver of promotional and educational materials of the assigned therapeutic areas, with a solid understanding of the labels, relevant clinical data (including real world evidence), scientific literature, and JPMA guidance;
- Possessing a high level of integrity with good ethical values at the core, embracing and embodying Our Credo;
- Possessing strong communication, organizational and analytical skills;
- Having familiarity with Japan’s promotional and educational material review process and its requirements;
- Being a creative and independent thinker, highly solution oriented, who proactively engages in meaningful discussion with the business to resolve issues and for alignment, eager to understand critical business needs;
- Being an effective listener and clear communicator who values clarity, consistency, and scientific rigor; and
- Having ability to successfully manage multiple projects simultaneously, if assigned, including vendor management
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensuring promotional and educational materials of the assigned therapeutic areas are created, reviewed, and disseminated in consistent with applicable J&J policy, laws, regulations and codes
- Working closely with his/her team members supporting the same therapeutic areas to ensure that their interactions with health care professionals and government officials are planned in consistent with HCC policies and procedures
- Partnering with the business to foster a culture of accountability, drive compliance ownership, and support ethical decision-making by the business
- Acting as a trusted advisor, providing day-to-day guidance and advice to covered employees especially in relation to promotional and educational materials
- Developing HCC training focused on promotional and educational materials and compliance with internal and external guidance on these areas and delivering appropriate trainings to covered employees at various levels
- Interfacing with local Medical Affairs, Legal, Regulatory and other functions regarding promotional and educational materials
- Interfacing with regional HCC colleagues and HCC’s Regulatory Advertising and Promotion team in the US to share approaches and best practices
- Other duties to drive an effective compliance program as part of the HCC organization may be assigned
EDUCATION and EXPERIENCE:
- Bachelor’s degree required, preferably in medical, pharmacy, and science or engineering; advanced degree is preferred
- Minimum of five years of experience in the pharmaceutical or medical devices industry, preferably in sales or marketing (or it could be regulatory, legal, medical affairs, compliance, commercial excellence, R&D and safety, and compliance) with some levels of experience in planning and executing speaker programs, interactions with healthcare professionals, and developing marketing plans and promotional materials (a plus if having experience in a product launch and/or oncology)
- Supervisory experience a plus, but not a must
- Knowledge of Japanese promotional activities and anti-corruption laws, regulations, and industry codes and guidance including the FCPA
SKILLS and ABILITIES:
- Ability to make and stand by difficult decisions
- Independent and objective thinking, with the ability to advance ideas and influence others
- Effective management of conflicts in an open and constructive manner.
- Curious by nature with a strong interest in serving patients with integrity and science
- Experienced in people development and management, a plus
- Native level in Japanese with excellent reading, writing, verbal skills especially to clearly understand and desirably communicate the science; fluency in English a huge plus if eager to expand the roles and responsibilities beyond Japan.
