Johnson & Johnson Health Care Compliance & Privacy is recruiting for a Director to serve as a Health Care Compliance (HCC) Officer for Johnson & Johnson company(s) within the Medical Device Sector. The company(s) have a global footprint however this position will be based near Irvine, California with the ability to travel to assigned J&J Companies both domestic and internationally.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $70 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.
The HCC Officer leads and drives the Health Care Compliance program to ensure business practices and activities are in compliance with J&J internal guidelines, regulations and legislative requirements by providing oversight, direction, guidance, and support to the business and senior management. They serve as a strategic business partner who provides policy interpretation as it relates to activities with health care compliance risks.
The HCC Officer will:
• Provide leadership, guidance, and support to all levels of organization on highly complex compliance issues, including policy interpretation, compliance risk assessment, trend analysis and best practice recommendations.
• Provide guidance and oversight to ensure integration of appropriate HCC policy into the development of strategic and tactical plans, forecasts, call plans and incentive compensation plan, as well as oversight relating to the execution of those plans. This includes oversight and/or review and approval of programs and processes
• Direct and conduct periodic reviews and updates to policies, ensuring clarity, applicability and alignment with higher level policies and external requirements, with minimal
• Advise Senior Management at the Company and periodically Sector VP of HCC of potential compliance risk areas and, recommend and implement appropriate action plans.
• Coordinate support and resources with the HCC Global Operations Group ("GLOPS") to ensure ongoing effectiveness of the HCC program; in particular, for the creation and implementation of appropriate HCC Training, Testing & Monitoring, and Tracking/Database Management.
• Implement internal controls so that they are capable of preventing and detecting significant issues or patterns of fraud and abuse. The role will also support HCC investigations in concert with the Sector Investigations Lead and the J&J Law Department and ensures appropriate and consistent application of HCC related disciplinary action.
• Participate on cross-functional and/or cross-company teams, provide oversight for Educational Grant committee and other compliance review functions, such as Contract and Pricing Committees and identified HCC task force’s
• Lead Compliance Committee and provide input on handling violations, review internal trends and implement corrective actions.
• Provide leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with the Legal Department, as appropriate, to propose solutions to the business.
• Select, recruit, mentor, coach, and develop team members.
• A minimum of a Bachelor’s degree is required; Masters in a related field or other advanced degree desirable.
• A minimum of 10 years of business experience, along with a minimum of 3 years of experience and demonstrated leadership in HCC, GCC, Privacy, or a related compliance field are required.
• People management experience is required.
• A proven track record of sustaining compliance in complex organizations is required; demonstrated experience in the development and implementation of a compliance surveillance program in accordance with the organization's risk profile is required.
• Experience with FDA advertising and promotional practices regulations (including DTC) for medical devices or pharmaceutical products, commercial aspects of marketing medical devices or pharmaceutical products, financial or related business functions is preferred.
• Experience creating and implementing policy is preferred.
• Experience with overseeing the development and presentation of appropriate employee education and training programs, including formal training and periodic education-related communications, is preferred.
• Knowledge of, and the ability to apply, HCC/fraud and abuse laws (AKS, FCA, FCPA), FDA regulatory promotional practices, financial or auditing practices (T&M), and company business and policies is required.
• Exceptional written and verbal communications skills are required.
• Occasional travel to domestic and some international (up to 25%) is required, depending on business need.
Johnson & Johnson International (6078)Job Function
Health Care Compliance