Regulatory Specialist

4 weeks ago

Philadelphia, United States Pennsylvania Medicine Full time

Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.

Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?

Summary:

  • Supports the Hospital of the University of Pennsylvania (HUP) and those parts of the Clinical Practices of the University of Pennsylvania (CPUP) which practice at or in conjunction with the hospitals within the University of Pennsylvania Health System (UPHS), operating under the licenses of said hospitals and its leaders and staff to ensure full compliance with state licensure regulations, hospital conditions of participation and accreditation standards. Actively participates and leads the organization's efforts to prepare for, take part in and respond to any necessary follow-up of both announced and unannounced regulatory body site visits with a focus on the Clinical Practices of the University of Pennsylvania. Responsibilities also include educating staff to hospital accreditation and licensure standards and regulations. Researches and completes applications, such as the Pennsylvania Department of Health (PA DOH) application and surveys, such as the American Hospital Association (AHA) survey. Actively works with policy owners to support current and develop new Administrative and Clinical hospital polices. Supports team projects and brings groups to consensus on strategies and/or actions necessary to improve clinical quality and/or safety outcomes. Develops, maintains and documents in requisite databases in order to track activities and ensure continuous process improvement and efficiency within the organization and department.
  • Demonstrates understanding of concepts, methods, techniques and principles needed to accomplish job responsibilities, such as PA DOH, The Joint Commission (TJC) and Center for Medicare and Medicaid Services (CMS) regulations.
Responsibilities:
  • Essential Accountabilities:Ensure internal clients are aware of services offeredSupports the vision of the UPHS Clinical Effectiveness and Quality Improvement DepartmentDevelop relationships within the organization to ensure effective communication and partnership / cooperation in all facets of the licensure and accreditation processCollaborate with leaders and staff to evaluate proposed rules / regulations and assess, develop, or participate in, as appropriate, regulatory advocacy approachesCoordinate with others, as appropriate, to resolve highly complex or unusual business problems impacted by proposed or final regulatory action or inaction affecting major functions or disciplinesOperations:Maintains a solid working knowledge of regulatory body regulations, including but not limited to, TJC, CMS, and PA DOHMaintains a working knowledge of quality outcome related publicly reported data and identifies areas where compliance is problematicWorks with individual clinicians and teams to identify methods to improve compliance with clinical quality indicators required by regulatorsMonitors consistency, validity, and reliability of data. Edits as appropriateCoordinates and participates in regulatory survey readiness activitiesCoordinates projects in support of clinical quality improvement, e.g., RCA and FMEA processes. Researches and completes surveys, such as the AHA survey, which describes institutional demographics and activitiesCoordinates quality team projects and brings groups to consensus on methods necessary to improve clinical quality outcomesFacilitates identification of future performance improvement initiatives and organizes appropriate team membersDevelops, documents in, and maintains databases necessary to track compliance activities and outcomes.Ensures that all initiatives are in compliance with accrediting, regulatory, and institutional standardsMaintains the confidentiality of all inter-departmental correspondence as well as the external clientsPrimary liaison with state agency, including but not limited to PA DOHCollaborates with physicians, administration and staff to achieve desired patient outcomesAssesses educational needs and provides information and instructional materials to HUP departmentsEducates staff on key policies and procedures and regulatory requirementsConducts Environment of Care rounds and assists in Patient Safety roundsServes as a liaison with HUP Pharmacy and Infection Control Departments to identify and solve patient care issues with HUP managers and staff
Credentials:

  • Registered Nurse - PA
Education or Equivalent Experience:

  • Bachelor of Arts or Science (Required)
  • Education Specialization: Equivalent Experience: •And Minimum 3-5 years of experience in healthcare management or healthcare education
  • Master of Arts or Science
  • Education Specialization: Masters of Science in Nursing (MSN) or equivalent Equivalent Experience:
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.

Live Your Life's Work

We are an Equal Opportunity and Affirmative Action employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.

  • Sr. Regulatory Affairs Specialist

    1 month ago

    Philadelphia, United States Proclinical Staffing Full time

    Sr. Regulatory Affairs Specialist - Contract - Philadelphia, PAProclinical is seeking a Senior Regulatory Affairs Specialist to join a dedicated team. Primary Responsibilities:The successful candidate will work independently on complex protocols, review and create core documents, and prepare health authority submissions. You will facilitate communications...

  • Regulatory Compliance Specialist

    6 days ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is a national staffing firm offering consulting, direct hire & outsourcing solutions in Scientific, Clinical Research, and Engineering fields. We're seeking a Regulatory Compliance Specialist to ensure compliance with cGMP regulations in our manufacturing processes. This role requires effective communication with cross-functional...

  • Regulatory Affairs Quality Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Disability Solutions Full time

    We are seeking a highly skilled Regulatory Affairs Quality Specialist to join our team in Philadelphia, PA.The estimated annual salary for this role is $80,000-$100,000 based on industry standards and location.About the RoleThis is a full-time position reporting to the QA Manager. The successful candidate will be responsible for ensuring compliance with...

  • Director Regulatory Affairs

    2 months ago

    Philadelphia, United States EPM Scientific Full time

    Job DescriptionJob DescriptionDirector of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health....

  • Regulatory Compliance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Planet Pharma. In this critical role, you will be responsible for ensuring compliance with Federal, State, and Local regulations governing waste management.About the RoleMaintain regulatory compliance by inspecting and identifying all forms of waste to determine...

  • Compliance and Regulatory Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States GREATER PHILADELPHIA URBAN AFFAIRS Full time

    Job DescriptionThe Greater Philadelphia Urban Affairs is seeking a highly skilled Compliance Coordinator to support our economic development projects. As a Compliance Coordinator, you will be responsible for managing construction projects to ensure compliance with regulatory requirements.This role involves working closely with project managers, site...

  • Senior level regulatory consultant

    1 month ago

    Philadelphia, United States Proclinical Staffing Full time

    Senior Level Regulatory Consultant - Contract - PhiladelphiaProclinical is working alongside a biotech seeking a Senior Level Regulatory Consultant to join the team. In this role, you will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and...

  • Regulatory Compliance Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States Comcast Corporation Full time

    About ComcastAs a leader in the media and technology industry, Comcast Corporation is committed to innovation and excellence. Our vision is to create cutting-edge products and services that meet the evolving needs of our customers.Job OverviewThis role plays a critical part in ensuring that our business operations are compliant with relevant laws and...

  • Regulatory Compliance Specialist

    3 weeks ago

    Philadelphia, United States Rivers Casino Full time

    Job Category: Regulatory Requisition Number: REGUL003866 Posting Details Posted: November 27, 2024 Full-Time Locations Rivers Casino Philadelphia 1001 N. Delaware Ave. Philadelphia, PA 19125, USA Job Details ...

  • Regulatory Compliance Specialist

    3 weeks ago

    Philadelphia, United States Rivers Casino Full time

    Job Category: Regulatory Requisition Number: REGUL003866 Posting Details Posted: November 27, 2024 Full-Time Locations Rivers Casino Philadelphia 1001 N. Delaware Ave. Philadelphia, PA 19125, USA Job Details ...

  • Regulatory Affairs Specialist

    5 days ago

    Philadelphia, Pennsylvania, United States JEVS Human Services Full time

    Job Summary">This Compliance Specialist role is part of our Work Ready program, which provides comprehensive employment-oriented services to individuals receiving Public Assistance benefits.">The successful candidate will have a strong background in human services and case management, with excellent analytical and communication skills.">The role involves...

  • Regulatory Compliance Specialist

    1 month ago

    Philadelphia, United States Rivers Casino Full time

    Engagement Expectations: We believe that team member engagement is the basis for a great culture and superior guest service. During every interaction, we display three behaviors: Smile, display energy and open body language Proactively greet team members and guests, initiating interaction to provide service Always use a positive parting remark to end the...

  • Proclinical Staffing | Senior level regulatory consultant | philadelphia, pa

    1 month ago

    philadelphia, United States Proclinical Staffing Full time

    Senior Level Regulatory Consultant - Contract - PhiladelphiaProclinical is working alongside a biotech seeking a Senior Level Regulatory Consultant to join the team. In this role, you will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and...

  • Regulatory Specialist

    5 days ago

    Philadelphia, Pennsylvania, United States Azzur Group Full time

    Benefits and CultureAzzur Group is committed to creating a positive and inclusive work environment, where our employees feel valued, supported, and empowered to succeed. We offer a range of benefits and perks, including:Health Care Plan (Medical, Dental & Vision)Retirement Plan (401k, IRA)Life Insurance (Basic, Voluntary & AD&D)Paid Time Off (Vacation, Sick...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Bethanna Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Bethanna, a non-profit Christian organization providing high-quality services for children and families. This role is responsible for ensuring compliance with state regulations and CUA contract standards.Key Responsibilities:Data Collection and Analysis: Collect,...

  • Compliance Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States LyTa Corporation Full time

    Job OpeningRusty Lantern Markets is hiring a Compliance Specialist to ensure the accuracy and integrity of our financial records, as well as compliance with regulatory requirements.Key Responsibilities:Compliance MonitoringFinancial Record ManagementReporting and AnalysisProcess ImprovementRegulatory ResearchRequirements:Previous experience in accounting or...

  • USITSP - Statistical Reporting Specialist

    3 weeks ago

    Philadelphia, United States NavitsPartners Full time

    Statistical Reporting SpecialistJob Purpose: Focus on creating comprehensive statistical reports and regulatory documentation for clinical studies.Key Responsibilities:Design and produce study-specific statistical reports.Validate data outputs for statistical accuracy.Collaborate on regulatory submissions and audits.Learn More

  • Pharmacy Auditor Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Pacer Staffing Full time

    Job Title: Pharmacy Auditor SpecialistLocation: Philadelphia, PAJob Type: ContractPay: $30.00 - $31.00 per hourAbout the JobThe Pharmacy Auditor Specialist will play a crucial role in ensuring compliance standards are met for outpatient pharmacy locations. This involves auditing claims for accuracy and appropriateness, conducting proactive audits, and...

  • Transplant Coordinator Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Pennsylvania Medicine Full time

    About the Role:The Transplant Coordinator Specialist position plays a critical role in maintaining high-quality care and meeting operational targets within the Transplant department. As a key member of our team, you will oversee daily schedules, manage staff performance, and ensure compliance with regulatory standards.

  • Accreditation Program Specialist

    18 hours ago

    Philadelphia, United States Thomas Jefferson University Hospital Full time

    Job Details Job Description 003427The Health System Wide Ambulatory Accreditation/Regulatory Specialist supports the ambulatory clinic /physician-based practices (PBP) (under the hospital licensure) throughout the Jefferson Health system to ensure compliance with state licensure regulations, CMS conditions of participations and Joint Commission standards....