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The licensed Clinical Content Developer RN, NP, PA develops and updates the clinical content of Optum Clinical Products.. The Clinical Content Developer is also responsible for quality assurance (QA) of the content and for responding to internal and external client questions and concerns.. We are looking for a licensed RN, NP, or PA, with a broad clinical background who can join our fully remote team and collaborate with us on the development of quality content for the InterQual suite of products.. Collaborate with Product Development (PD), Product Management (PM), Product Owner (PO), and Business Systems Analyst (BSA) as needed. Experience with utilization management (UM), case management, or use of evidence-based guidelines such as InterQual/Clinical Decision Support applications or Medicaid State Policies.
Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. Must be able to demonstrate a working knowledge of laws and regulations governing Medicare, Medicaid and other funding sources. Manages clinical denials, educating referring providers on clinic and payor requirements. Oncology Services Only: Will maintain current Commission on Cancer specific certification in the nurse’s specialty by an accredited certification program or will continue ongoing education by earning 12 cancer-related continuing education nursing contract hours per year or 36 cancer-related continuing education nursing contract hours each accreditation cycle (3 years). As part of our commitment to our patients and employees’ wellness, Parkland Health is a tobacco and smoke-free campus.
Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care.. - Must be able to demonstrate a working knowledge of laws and regulations governing Medicare, Medicaid and other funding sources.. Manages clinical denials, educating referring providers on clinic and payor requirements.. Oncology Services Only: Will maintain current Commission on Cancer specific certification in the nurse's specialty by an accredited certification program or will continue ongoing education by earning 12 cancer-related continuing education nursing contract hours per year or 36 cancer-related continuing education nursing contract hours each accreditation cycle (3 years).. As part of our commitment to our patients and employees' wellness, Parkland Health is a tobacco and smoke-free campus.
By integrating deep molecular profilingincluding genomics, proteomics and the immune systemthe platform delivers a systems biology view that accelerates drug development and clinical decision-making. QMS Maintenance and Improvement: Oversee the maintenance and continuous improvement of the QMS, including internal audits, corrective and preventive actions (CAPA), and change control management within both GCLP and CLIA frameworks. Team & Organizational Leadership: Build and lead high-performing Regulatory and Quality teams with a focus on QMS management, GCLP/CLIA compliance, and cross-functional integration across laboratory, product development, and software teams. FDA and PMDA Device Regulations: Knowledge of pre-market submissions, post-market surveillance, and QMS requirements for medical devices. Background in oncology, molecular diagnostics, or bioinformatics services with specific knowledge of AI/ML applications.
Ensure coding accuracy and compliance with CMS, Medicare, Medicaid, and state-specific requirements. Requirements:CPC (Certified Professional Coder), CCS (Certified Coding Specialist), CCA (Certified Coding Associate), or CRC (Certified Risk Adjustment Coder). Associate's or Bachelor's degree in Health Information Management, Medical Coding, or a related field preferred. 3+ years of ICD-10 coding experience in long-term care (LTC), skilled nursing (SNFs), assisted living, or senior living settings. Familiarity with Electronic Health Record (EHR) systems and coding software.
Job Title: Medical Billing Specialist. Join JTS Health Partners as an Medical Billing Specialist and play a vital role in enhancing cash performance for hospitals and healthcare organizations.. Utilize portals such as Availity, Optum, MMIS, and Medicare contractors.. 1+ year of experience in hospital back-end revenue cycle functions (denials, billing, cash applications, etc.). Knowledge of claim submission, insurance follow-up, and remittance analysis.
Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.. Oversee post-market surveillance, adverse event reporting, and regulatory audits.. 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.. Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.. Official offers are sent through Docusign after a verbal offer, not via text or email.
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development.. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine.. Assist with the collection of biological samples, perform venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor's written orders.. In executing these responsibilities, the Patient Care Technician is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.. Perform basic lab procedures as delegated including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups.
The wage for this position is $60,000 Benefits eligible positions include a comprehensive benefits package which offers: Health, Dental, Vision, Life, Disability & AD&D insurance; a defined benefit pension plan; paid leaves such as Vacation, Holiday and Sick; tuition waivers for employees and dependents.. Remote work: This position requires on-site presence initially and can transition into a hybrid role eventually.. Notify and inform physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee and grant sponsors.. Experience in a clinical research setting, experience working with Federal Regulations and IRB’s required.. Preferred Qualifications Certified Clinical Research Coordinator (CCRC) preferred.
Regulatory Affairs & Quality Assurance (QA) Specialist. Arrae is seeking an experienced and detail-oriented Regulatory Affairs & QA Specialist to ensure our products meet the highest regulatory and quality standards.. Ensure the company complies with all health and safety regulations for dietary supplements (e.g., FDA, GMP) and prepares products for e-commerce and retail channels.. Conduct testing to ensure product safety and meet all regulatory standards for dietary supplements.. Interested candidates are invited to send their resume to careers@arrae.com with the subject line "Regulatory Affairs & QA Specialist".
Quality Assurance and Regulatory Affairs Manager. Quality Assurance and Regulatory Affairs Manager Location: Rosemont, IL, United States. Position Summary: We are seeking an experienced Quality Assurance and Regulatory Affairs Manager to join our team.. Key Responsibilities: Regulatory Affairs : Lead the preparation and submission of regulatory filings for ASRs , IVD products , and DMFs to health authorities such as the FDA, EMA, and other global regulatory bodies.. Manage the regulatory registration process for IVD products, including risk assessments, technical documentation, and post-market surveillance requirements.
Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen.. Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.. Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.. Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.. Learning & Development Opportunities: On-demand online training and book reimbursement
Provides legal expertise on company-wide initiatives, which may require legal research and advice related to various parts of the CVS Health enterprise.. Works collaboratively and cross functionally with a variety of areas including other members of the legal department, Compliance, Government Affairs, Regulatory Affairs, and business operations teams to implement new laws and regulations for assigned areas.. In-house Counsel Certification (ICC) preferred.. Healthcare laws and regulations including for example, ACA, Medicare, Medicaid, AWP/parity, pharmacy and/or mental health parity.. No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.. Oversees operational aspects of trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.. Systemic route of administration clinical trials experience required; pediatric, drug/device combination device, device, and/or biologics experience preferred.. Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
Demonstrated experience in communicating effectively, both verbally and in writing, with physicians, nursing, public, and all levels of hospital management.. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.". Providence has been serving the Pacific Northwest since 1856 when Mother Joseph of the Sacred Heart and four other Sisters of Providence arrived in Vancouver, Washington Territory.. Our not-for-profit network also provides a full spectrum of care with leading-edge diagnostics and treatment, outpatient health centers, physician groups and clinics, numerous outreach programs, and hospice and home care.. Providence St Vincent Medical Ctr-Portland
Responsible for increasing membership through direct sales and marketing of Molina Medicare products to dual eligible, Medicare-Medicaid recipients within approved market areas to achieve stated revenue, profitability, and retention goals, while following ethical sales practices and adhering to established policies and procedures.. Develop sales strategies to procure sufficient number of referrals and other self-generated leads to meet sales targets through active participation in community events and targeted community outreach to group associations, community centers, senior centers, senior residences and other potential marketing sites.. Ensure Medicare beneficiaries accurately understand the product choices available to them, the enrollment process (eligibility requirements, Medicare review/approval of their enrollment application, timing of ID card receipt, etc.). 2+ years Medicare, Medicaid, managed care or other health/insurance related sales experience. To all current Molina employees: If you are interested in applying for this position, please apply through the intranet job listing.
This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system.. This role will interface with other Insulet departments (e.g. Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system.. Note: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller.
Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required.. The hospital offers a level III Neonatal Intensive Care Unit (NICU) through a partnership with Lucile Packard Children’s Hospital Stanford.. Neurosurgery at Dominican is also offered through a partnership with Stanford Health Care.. Quality Assurance Manager, Trust & Safety - USDS San Jose, CA $135,000.00-$241,200.00 1 week ago. Quality Assurance Manager, eero B2B team Quality Control Manager (Construction/OSHPD) Quality & Safety Improvement Consultant IV, Clinical Quality Consulting Quality Patient Safety Program Manager Clinical License Assurance Manager, Quality Management - IS Assurance San Jose, CA $100,000.00-$150,000.00 1 week ago
Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases.. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals.. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred. Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases.. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals.
Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.. Oversee post-market surveillance, adverse event reporting, and regulatory audits.. 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.. Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.. Official offers are sent through Docusign after a verbal offer, not via text or email.