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MCRA's value contribution rests within its industry experience at integrating five business value creatorsregulatory, clinical research, reimbursement, healthcare compliance, and quality assuranceto provide a dynamic, market-leading effort from concept to commercialization.. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.. MCRA, an IQVIA Business is seeking a Director, Cybersecurity Regulatory Affairs with working knowledge and experience with FDA requirements for cybersecurity to provide consulting advisory services to MCRA clientele.. As a critical piece of MCRAs Digital Health programs, this position will support medical device regulatory and FDA cybersecurity knowledge for the client product lifecycle from device development, through and beyond device deployment.. Knowledge of threat modeling, penetration testing, cybersecurity research, and knowledge of encryption technologies, ethical hacking, and endpoint security tools is preferred
MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO).. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.. MCRA, an IQVIA Business is seeking a Director, Cybersecurity Regulatory Affairs with working knowledge and experience with FDA requirements for cybersecurity to provide consulting advisory services to MCRA clientele.. As a critical piece of MCRAs Digital Health programs, this position will support medical device regulatory and FDA cybersecurity knowledge for the client product lifecycle from device development, through and beyond device deployment.. MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices.
The ICU Registered Nurse is responsible for providing specialized care to patients with life-threatening conditions or comorbidities that require advanced organ support and invasive monitoring.. Ensure timely and accurate documentation of patient care using electronic health record (EHR) systems, particularly EPIC.. Maintain patient safety standards and infection control practices in a critical care setting.. Current ACLS (Advanced Cardiovascular Life Support) certification (AHA).. Proficiency with computer charting and electronic health records (EHR), specifically with EPIC.
The Clinical Trials Nurse, under the guidance and supervision of the Principal Investigator (PI), ensures that the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, as well as ensures that Institutional Review Board (IRB) approvals are obtained and Office of Regulatory Research Compliance (ORRC) policies and procedures are followed. Functions as an expert research nurse and coordinates and manages the clinical trials program. Assists in identifying and writing research grants, publications in medical and nursing literature, study materials, brochures, and correspondence. Assists the Principal Investigator (PI) with participant evaluation as detailed in the protocols submitted by the sponsor. Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
Summary: The ideal candidate will have experience in medical billing, claim processing, and a solid understanding of medical insurance.. General Description: The Medical Billing Specialist is responsible for both institutional and professional claims management and processing for the hospitals and clinics.. Accurately prepare and submit medical claims to private insurance companies and government agencies (e.g., Medicare, Medicaid, VA, Tricare) for facility claim payment.. Possess a strong working knowledge of EMR systems such as; Cerner , Meditech , Athena , and Epic , as well as other healthcare software and insurance web portals.. Demonstrate familiarity with ICD-10, CPT, and HCPCS codes.
Evolent Health Care Opportunity.. Utilizes medical/clinical review guidelines and parameters to assure consistency in the MD review process to reflect appropriate utilization and compliance with SBU's policies/procedures, as well as Utilization Review Accreditation Commission (URAC) and National Committee for Quality Assurance (NCQA) guidelines. Participates in on-going training per inter-rater reliability process. May assist the Senior Medical Director in research activities/questions related to the Utilization Management process, interpretation, guidelines and/or system support. Not under current exclusion or sanction by any state or federal health care program, including Medicare or Medicaid, and is not identified as an "excluded person" by the Office of Inspector General of the Department of Health and Human Services or the General Service Administration (GSA), or reprimanded or sanctioned by Medicare.
Test & Triumph: Validate software features, fixes, and performance through functional, smoke, end-to-end, and regression testing.. Escalation Expert: Assist teams like Development, Implementation, Sales, and Tech Support by digging into escalated issues, identifying workarounds, and documenting everything for smooth resolution.. QA Conductor: Collaborate with your fellow QA pros to refine our testing strategy, develop new test cases, and coordinate test rack management.. Bonus Points: Experience with JavaScript, Linux, or macOS is a plus-but not required!. Professional Growth: Step into a role that offers endless opportunities to expand your QA toolkit and test new horizons in software quality assurance.
This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). Advanced understanding of drug development principles and clinical trial implementation and management. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Become a part of our caring community and help us put health first. The clinical scenarios predominantly arise from inpatient or post-acute care environments.. Some roles include an overview of coding practices and clinical documentation, grievance and appeals processes, and outpatient services and equipment, within their scope.. The Medical Director may speak with contracted external physicians, physician groups, facilities, or community groups to support regional market priorities, which may include an understanding of Humana processes, as well as a focus on collaborative business relationships, value-based care, population health, or disease or care management.. May also engage in grievance and appeals reviews.
Johnson & Johnson is recruiting for a Director, Pharmaceuticals, Federal Affairs role to support the Federal Innovative Medicine portfolio focused on leadership in public policy, legislative, advocacy and political issues.. Develop, implement and direct federal lobbying activities in support of the corporations legislative and policy priorities related to the Innovative Medicine business.. Direct external political consultants, engage and manage key stakeholder industry coalitions, and collaborate with cross functional partners including U.S. Policy, Public Affairs and State Government Affairs.. A minimum of 10 years of experience in government, government affairs, healthcare policy and/or public policy arena.. Ability to manage internal team, external policy consultants, engage key stakeholder industry coalitions, and collaborate with state government affairs is required.
Regulatory Compliance : Ensure that all clinical trials adhere to regulatory bodies such as the FDA and comply with Good Clinical Practice (GCP) guidelines.. Clinical Research Coordinator certification (ACRP-CRC or SOCRCCRC) preferred. Experience working on multi-site or national studies Expertise in regulatory submissions and IRB processes Experience working with NIH, CMS, or FDsponsored studies is highly desired. Experience with electronic regulatory and EDC platforms Proficiency in research database tools (e.g., REDCap , Medidata Rave). All applicants must be US citizens and able to obtain a Public Trust clearance.
Director of Nursing (DNS). Enumclaw Health and Rehabilitation Center is looking for a Director of Nursing (DNS) to manage the day-to-day operations, activities and success of the resident care staff.. Enumclaw Health and Rehabilitation Center. Preferred: Certification in Rehab Nursing, geriatrics, or psychiatric nursing. UKG Wallet - Work Today, Get Paid Tomorrow!
Have a masters degree in Nursing, Healthcare Administration, Public Health, or Business strongly preferred. A minimum of seven (7) years progressively responsible management experience in the areas of case management, population health and/or disease management required, including a minimum of five (5) years progressive experience working with medical and behavioral case management required. Administers and ensures care management programs meet compliance and regulatory standards as required by Centers for Medicare & Medicaid Services (CMS), DSNP Model of Care (MOC), Washington Health Care Authority (HCA), and/or National Committee on Quality Assurance (NCQA) for continued accreditation of the health plan, as well as state and federal regulations, quality metrics and evolving models of care.. Knowledge of the various components of managed care (quality improvement, disease management, population management, utilization management, and case management) and how they link.. Knowledge of regulatory and certification requirements and their impact on the organization (for example, HEDIS, CAHPS, and NCQA).
The Managing Director will apply leadership technical experience in healthcare related fraud and take a leadership role in building out the Forensic Healthcare advisory practice.. The Managing Director will serve as a designated point of contact with client personnel on engagements, thus good communication skills and a strong presence is required.. The Managing Director will also be responsible for business development initiatives, go to market strategies, thought leadership and revenue generation targets.. Acts as Career Advisor to Managers, Senior Associates and Associates. Experience with medical billing practices, government programs such as Medicare and Medicaid, HIPAA, regulatory compliance, clinical coding & medical billing review, CID, False Claims/Qui tam, preferred
Anglin Consulting Group helps our clients augment their existing in-house capabilities and deliver expert counsel to keep them efficient and relevant in today's dynamic marketplace.. Ensure projects adhere to healthcare industry regulations and standards, including HIPAA, FDA guidelines, and other relevant compliance requirements.. Bachelor's degree in healthcare administration, business management, or a related field.. Strong knowledge of healthcare regulations and compliance requirements, such as HIPAA, Medicare, and Medicaid.. Project management certification (PMP or equivalent) is a plus, demonstrating a commitment to professional development and industry best practices.
Providence St Joseph Health operates a self-administered claims program for General and Healthcare Professional Liability, Directors and Officers, Employment Practices, Fiduciary, Property, Cyber, Managed Care, and Auto Claims.. The Senior Quality Analyst is also responsible for maintaining a claims quality assurance program, management of projects and continual learning, data integrity, settlement and excess reporting, payor contracting and other regulatory reporting requirements governing liability claims handling.. Ensure compliance with applicable laws, insurance regulations, settlement reporting, and other regulatory reporting requirements governing liability claims handling. Develop and provide training, job aides and technical support for caregivers regarding Centers for Medicare and Medicaid Services (CMS) Medicare Secondary Payer reporting, applicable laws, insurance regulations, and other regulations relating to investigating, evaluating, and resolving liability claims.. Bachelor's Degree in Business Administration, Public Health Administration, Organizational Leadership, Finance, or a related discipline -OR- a combination of equivalent education and work experience
MCRA, an IQVIA business is seeking a strong Senior Associate to join our Regulatory Affairs team. Draft usability engineering file, conduct use related risk analysis, conduct post-market surveillance data analysis, design usability studies and draft protocols, support usability study execution and report drafting. Surgical and clinical shadowing experience or cadaver lab experience beneficial. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters.. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives.. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products)
Patient Safety & Quality: Develops, leads tracers and engages with PI teams to dive deeper into clinical operations using the tracer methodology to identify best practices, trends, areas for improvement and monitor planned change.. Regulatory Readiness: Prepares hospital applications for The Joint Commission, District of Columbia Hospital License, and Centers for Medicare and Medicaid Mental Health.. Compliance Support: Ensures compliance with Joint Commission standards and DSC Stroke Standards and leads and coordinates hospital-wide Joint Commission preparation and on-going compliance.. Regulatory Readiness: Conducts regular readiness tracer activities in partnership with other internal subject matter experts such as infection prevention, pharmacy, nursing and report findings to appropriate leaders.. CPHQ - Certified Professional in Healthcare Quality within 1 Year preferred and
TITLE: Quality Assurance Manager.. POSITION SUMMARY: The Quality Assurance (QA) Manager ensures that PHRI’s programs and services meet high standards of quality, safety, and compliance. The QA Manager collaborates with leadership and clinical teams to maintain accreditation standards (e.g., CARF, The Joint Commission), promotes evidence-based practices, and fosters a culture of accountability. Knowledge of CARF, The Joint Commission, Medicaid/Medicare compliance, HIPAA, and 42 CFR Part 2. AAP/EEO STATEMENT: It is the policy of Prestige Healthcare Resources, Inc. to provide equal employment opportunity (EEO) to all persons regardless of citizenship, disability, creed, expression, genetic information, marital status, public assistance status, veteran status, or other protected characteristics.