[MED/HCC] Specialist, Health Care Compliance
Auris Health
Description
SUMMARY:
Implements the Health Care Compliance (HCC) program locally under supervision of the HCC Officer of MedTech Japan to ensure business practices and activities are in compliance with related J&J internal guidelines, local laws and regulations and anti-corruption laws including the Foreign Corrupt Practices Act. Serves as a strategic business partner for local management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day-to-day business.
This position reports to the Sr. Manager, MedTech Japan, and is located in Tokyo, Japan.
PROFILE:
- Requires strong communication, organizational and analytical skills
- Broad business experience and a proven ability to influence business decisions and business partners
- Ability to take complex business situations and develop solutions to ensure compliant growth is achieved
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Regulatory or Auditing.
- Proven track record in delivering results, self-starter and ability to manage complexity a must
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Partnering with business unit and/or department leadership team to ensure compliance ownership and right tone at the top
- Support ethical decision-making capability within the business by participating business unit and/or department leadership team meeting, reviewing promotional strategies and other significant business initiatives
- Ensure business activities with health care professionals (HCPs) and government officials (GOs) are planned in consistence with applicable HCC policies and procedures
- Acting as a consultant, provide day-to-day guidance, advice to covered employees, including providing metrics as required by the HCC Officer based on risk assessment and other compliance program
- Deploy HCC policies and/or procedures in covered business unit and/or department by providing necessary training and/or communication to covered employees, managing changes, and monitoring implementation
- Tailor HCC training materials to fit into the needs and business context of covered business unit and/or department, and deliver appropriate trainings to covered employees at various levels such as business unit/department leadership, regional level, and/or territory level
- Participate in company HCC monitoring program to identify warning signals and/or gaps, and provide meaningful feedback to business unit/department leadership so that appropriate corrective actions are taken accordingly
- Manage risks involving third party intermediaries by implementing the due diligence process in covered business areas, including training to business sponsors, reviewing due diligence questionnaires, etc.
- Implementing and following up on the Management Action Plan, and guide the business partners to close gaps and implement corrective actions
- Implementing the escalation process for serious allegations, as appropriate, and assist investigation related to covered business areas
- Stimulating and contributing to innovative approaches towards HCP’s and GOs consistent with the HCC guidelines and framework.
- Interface with legal counsel regarding HCC requirements and interpretation.
- Interface with the regional HCC community to share approaches to HCC
Qualifications
EDUCATION and EXPERIENCE:
- Minimum of BA/BS required; MBA or any other advanced degree preferred but not required
- Minimum of 7 to 9 years business, legal and/or compliance-related experience
- Knowledge of laws, regulations and industry standards for Japan, as well as the Foreign Corrupt Practices Act
SKILLS and ABILITIES:
- Breadth of experience in all areas of: (1) compliance and regulation; (2) devising and implementing standard operating procedures; (3) testing and monitoring; and (4) training.
- Independent and objective thinker, able to advance ideas and influence others
- Manages conflicts in an open and constructive manner
- Demonstrate strong organisational, interpersonal and communication skills
- Deals well with ambiguity
- Excel at developing and maintaining effective partnerships and working relationships with key stakeholders at all levels of organisation 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
- Fluent in English (reading, writing, verbal)
- High level of integrity with good ethical core values
- Fluent in Japanese required