Manager Regulatory Affairs

About Jefferson

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow#39;s professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educashy;tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

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PRIMARY FUNCTION:

The Manager, Regulatory Affairs, plays an integral role in the design, development, and implementation of Jeffersonrsquo;s robust compliance program to ensure that all members of the Jefferson community understand and act in accordance with applicable laws and regulations across all business units and service lines. The Manager, Regulatory Affairs will assist with development and execution of Jeffersonrsquo;s regulatory strategy and will function as a trusted resource for stakeholders responsible for adhering to specific regulatory requirements.

ESSENTIAL FUNCTIONS:

middot; Ensures that Jeffersonrsquo;s regulatory guidance documents, policies, and procedures align with all applicable requirements and that members of the community understand how to comply.

middot; Serves as a primary resource for division regulatory leaders to ensure that Jefferson receives and acts upon newly identified regulatory standards and requirements.

middot; Services as enterprise liasion to stakholders who are responsible to address, respond to, investigate, and remediate issues that rise to the level of Department of Health or related agency inquiries.

middot; Leads or participates in meetings with internal stakeholders and external business partners or teams to communicate regulatory guidance and strategies.

middot; Provide critical review of and support for development of timely responses to regulatory questions and inquiries from external agencies.

middot; Maintains current knowledge of relevant regulatory guidance, laws and regulations, and proposed and final rules which affect clinical and educational services delivered by Jefferson entities.

middot; Liaises with regulatory and operations staff to ensure provide project support, as appropriate.

middot; Oversight and Annual updating of enterprise compliance department policies and procedures

middot; Directly oversees:

o Compliance Systems designed to communicate regulatory compliance directives and strategies to appropriate stakeholders.

o Regulatory aspects of annual compliance training, including management of all attestations and certifications related to Jeffersonrsquo;s compliance with various contractual and regulatory obligations

o Maintain the fidelity and relevance of Jeffersonrsquo;s Code of Conduct.

o Project Management and planning for all regulatory compliance-related training and education.

middot; Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.

BA/BS degree is required. Advanced degree (Health Care Compliance, Health Care Administration, Population Health, M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related health care field preferred.

Health Care Compliance Certifications preferred.

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Minimum of five (5) years of progressively responsible experience in healthcare or related regulatory fields. Experienced leader, with a minimum of 3 years of investigations, regulatory oversight or related experience preferred. Proficiency with compliance technology systems, process design experience and/or active participation in systems-related projects desired.

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ADDITIONAL INFORMATION:

Highly proficient in the suite of Microsoft Office applications, Ability to bring and act on new ideas to improve processes and systems. Excellent writing, analytical, problem solving, and critical thinking skills with proven ability to make high impact decisions.