Regulatory Compliance Monitoring Lead Analyst, Medical Devices
Johnson & Johnson, Health Care Compliance & Privacy (HCCP), Medical Devices (MD) is currently recruiting for a Regulatory Compliance Monitoring Lead Analyst.
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 $71.9 billion in 2016 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 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. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
HCCP is responsible for the implementation of programs designed to ensure that J&J companies meet statutory and regulatory requirements relating to health care fraud and abuse; as well as advertising and promotion laws governing the company's commercial and scientific activities. The Lead Analyst, Medical Devices Regulatory Compliance Monitoring will monitor business activities related to medical device regulatory requirements including ground breaking medical technologies, collaborations, acquisitions and new products. This position will report to the Director, Medical Devices Monitoring & Regulatory Compliance.
As the Regulatory Compliance Monitoring Lead Analyst, you will:
• Conduct monitoring of FDA regulatory promotional practice laws, regulations, policies and guidelines.
• Develop a robust monitoring work plan for the medical device businesses based on risk assessment.
• Execute monitoring plan with a focus on appropriate promotion including third party collaborations, acquisitions, new business models, products with novel technologies, field-based staff, advisory boards, professional education, copy approval, etc.
• Work with Health Care Compliance Officers and Regulatory Affairs to lead the effort to identify and execute monitoring solutions for areas identified during the risk assessment process.
• Monitor the compliance effectiveness of the Regulatory Affairs process harmonization initiatives to ensure alignment to the medical device businesses and the J&J enterprise-wide regulatory function.
• Cultivate collaborative relationships with HCCOs and business partners, providing recommendations and guidance to address risk remediation plans from monitoring results.
• Develop executive summary metrics and dashboards customized to each business unit using data analytics tools.
• Partner with and support global medical device centers of excellence monitoring initiatives.
• Contribute to project teams that support the overall global HCCP organization.
• Responsibility may include the supervision of a contractor(s).
• A minimum of a Bachelor's Degree is required.
• A minimum of six (6) years of regulatory experience required.
• Experience working in a Pharmaceutical, Biologics or Medical Device industry is required.
• Experience working with databases, data analytics and data visualization tools is preferred.
• This position requires a highly-motivated individual with strong analytical skills, intellectual curiosity and proven leadership skills.
• Strong communication, presentation, interpersonal, negotiating and influencing skills is required.
• Proven track record of taking risks and a demonstrated self-starter is required.
• Demonstrated forward thinking and continuous improvement mindset is required.
• Ability to multi-task and manage conflicting priorities independently is required.
• Must be able to travel up to 15%-20% of the time, mainly to domestic destinations with potential for international, depending on business need.
United States-New Jersey-Somerville
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham
Johnson & Johnson Services Inc. (6090)
Health Care Compliance
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