Collecting information
Organizing data
Children's Health (Dallas) is seeking a Registered Nurse (RN) Quality Assurance for a nursing job in Plano, Texas. Job Title & Specialty Area: Patient Safety Specialist.. Through our cutting-edge treatments and affiliation with UT Southwestern, we strive to deliver an extraordinary patient and family experience, ensuring that every moment, big or small, contributes to their overall well-being. Adoption and surrogacy reimbursement.. Posted job title: RN Quality Assurance
This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. Managing packaging, labeling, and distribution of clinical trial material for global clinical trials.. · Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material. NSIDE, Bioclinica, 4G, Oracle, etc)
This hybrid role involves both talent acquisition and client relationship management within the pharmaceutical, biotech, and CRO sectors.. Source, screen, and qualify candidates for roles in drug development, regulatory affairs, clinical trials, R&D, QA/QC, and other pharma-related functions.. Manage the full recruitment life cycle from posting to placement using ATS and sourcing platforms (LinkedIn, job boards, referrals).. Experience working in a staffing agency, consulting firm, or RPO serving the life sciences sector.. Exposure to top-tier pharma and biotech clients.
This opportunity is ideal for individuals aiming to build a career in regulatory affairs or quality assurance.. Provide administrative and document support to the Regulatory Compliance Manager, including formatting, scanning, and tracking.. Help gather materials required for renewals of certifications such as kosher, halal, and organic.. 1–3 years of experience in regulatory, quality, or compliance – ideally within the food, flavor, or fragrance sector.. Skilled in Microsoft Excel and electronic document management systems.
CommuniCare Corporate - Medicare BillerThe CommuniCare Family of Companies currently owns/manages over 100 World-Class Nursing and Rehabilitation Centers, Specialty Care Centers, and Assisted Living Communities throughout Ohio, Missouri, Pennsylvania, Indiana, West Virginia, Virginia, and Maryland.. Since 1984, CommuniCare Health Services has provided superior, comprehensive management services for the development and management of adult living communities.. CommuniCare Health Services is currently recruiting a Medicare Biller for our Central Billing Office in Cincinnati, OH.PURPOSE/BELIEF STATEMENTThe position of Medicare Biller is responsible for billing, receivables auditing, and collections activities for services provided to patients in the facilities assigned.. Ultimately they are responsible for hitting their cash collection goals each month and minimizing the impact of Bad Debt for the buildings/facilities assigned to them.. Other various duties as assignedAbout UsA family-owned company, we have grown to become one of the nation’s largest providers of post-acute care, which includes skilled nursing rehabilitation centers, long-term care centers, assisted living communities, independent rehabilitation centers, and long-term acute care hospitals (LTACH).
As our next Insurance & Medical Billing Specialist with Thrive's partner clinic, you'll be the connection point between medical care, insurance providers, and patients.. Translate clinical information into accurate superbills using CPT, ICD-10, and HCPCS codes.. Follow up with insurance providers to resolve claim denials and discrepancies.. Maintain organized records and ensure compliance with payer guidelines and HIPAA.Support efficient workflows using EHR systems and billing software.. Working knowledge of medical coding standards (CPT, ICD-10, HCPCS).
You will supervise nursing care provided by registered nurses, licensed vocational/practical nurses and STNA/CNAs. At Ciena Healthcare, we take care of you too, with an attractive benefit package including: Competitive pay Life Insurance 401 K with matching funds Health insurance AFLAC Employee discounts Tuition Reimbursement Responsibilities Some of your responsibilities include: Schedule and perform resident rounds to monitor and evaluate the quality and appropriateness of nursing care.. Participate in the budget process of the facility and maintains the nursing supply, equipment and nurse staffing budgets.. Education and/or Experience: RN license in the state Director of Nursing, management or supervisor experience in long-term care, restorative or geriatric nursing.. About Ciena Healthcare Ciena Healthcare is Michigan’s largest provider of skilled nursing and rehabilitation care services.. If you have a passion for improving the lives of those around you and working with others who feel the same way, Ciena is the place for you!
QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration.. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs. Ph. D., with at least seven years of pharmaceutical drug development experience relating to: systems biology, PKPD, pharmacometrics, mathematics, chemical/biomedical engineering or related field.. Antibody Drug Conjugates (ADC), Clinical Pharmacology, Data Modeling, Data Modeling Software, Data Modeling Tools, Data Visualization, Drug Development, Pharmacology Research, Pharmacometrics, Regulatory Documents. C (Programming Language), Clinical Trials, MathWorks SimBiology, MATLAB, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, Pharmaceutical Development, PKPD Modeling, Programming Languages, Regulatory Submissions, R Programming, T Cells
A leading biopharmaceutical company is seeking a Senior Director, Biostatistics to lead statistical strategy and operations across clinical development programs.. This role will work closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Pharmacology, Data Management, and Translational Medicine, to ensure the rigorous design, analysis, and interpretation of clinical data.. Lead and mentor the biometrics team, providing strategic input and statistical expertise across clinical programs.. 15+ years of statistical experience in drug development, with at least 10 years focused on oncology.. This position offers an exciting opportunity to play a critical role in advancing oncology drug development within a highly collaborative and innovative environment.
This position sits within the Office of Research and Development and plays a significant role in structuring and negotiating basic-, service- and clinical-research agreements with corporate sponsors, and other collaborating organizations.. Juris Doctor is strongly preferred and may substitute for required experience.. Familiarity with intellectual property, technology transfer, conflict of interest and conflict of commitment concepts.. Familiarity with development of corporate-sponsored research budgets for both basic and clinical research projects, including a basic understanding of Medicare coverage analysis and billing concepts associated with clinical trials.. Individuals may report concerns or questions to the Title IX Coordinator.
The Johns Hopkins Hospital is a world-renowned leader in patient care, serving the greater Baltimore community and patients from all across the globe.. Assists in development, revision and/or monitoring of laboratory procedures and quality assurance programs including proficiency testing and regulatory compliance.. Frequent travel throughout JHM geography / to each campus or affiliate hospital is required (when assigned).. For surgical pathology, certification from an approved agency as a pathologist assistant, histology technologist (HTL), medical technologist or equivalent required.. HATS QA Specialist- additionally certified as an inspector for FACT/Apheresis Collections, CQIA, SSGB, Patient Safety Cert program, preferred.
We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.. The Associate Director of Global Regulatory Affairs & Safety serves as a key point of contact for GRAIL’s UK Responsible Person (UKRP).. Support the legal manufacturer (GRAIL US) in preparation and delivery of required regulatory reports, e.g. annual reports to the MHRA according to regulatory reporting timelines for marketed products in assigned jurisdictions.. Experience in diagnostics or biomarker development with emphasis on oncology is a plus.. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care.. The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS).. This position is fully remote.. No experience needed for a CRDS I. 1-2 years of previous data entry experience as a clinical research coordinator, clinical research assistant or data entry specialist for therapeutic clinical trials to be considered for a CRDS II.. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts.
Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities.. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well.. At Baylor Scott & White Health, your well-being is our top priority.. Reporting to the CNO, DFW Central Region & Baylor University Medical Center (BUMC), the VP Patient Care - BUMC is responsible for overseeing, planning, and directing the nursing practice and clinical services for Baylor Scott and White Health (BSWH).. Baylor University Medical Center is a 5-time Magnet Designated Level I Trauma Academic Medical Center.
pioneer an integrated approach to stroke recovery, combining FDcleared brain-computer interface technology with personalized telehealth services.. The company’s IpsiHand device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function in daily home use.. Kandu extends recovery beyond the hospital through principal illness navigation, providing one-on-one education, care coordination, and advocacy; grounded in clinical evidence and informed by the lived experiences of patients and their families.. Lead the revision and harmonization of quality documents and procedures to achieve a unified and compliant QMS.. Serve as the primary point of contact for quality-related matters with a key global electronics manufacturing supplier.
Director, Clinical Research, Atherosclerosis page is loaded Director, Clinical Research, Atherosclerosis Apply remote type Hybrid locations USA - New Jersey - Rahway USA - Massachusetts - Boston (MA Parcel B Laboratory) time type Full time posted on Posted 3 Days Ago time left to apply End Date: June 27, 2025 (4 days left to apply) job requisition id R343073. The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area.. Minimum of 1 year of industry experience in drug development or biomedical research experience in academia. Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The company is also recruiting for talented scientists who have deep knowledge in immunology, translational science, bioinformatics and biologics platforms to develop novel drugs leveraging disease-driving biology, novel technology in protein engineering, antibody discovery and new modalities.. Data Analysis and Interpretation Oversee the analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure-response relationships, and safety/tolerability profiles.. Cross-Functional Collaboration Collaborate closely with colleagues in data sciences, biologics, immunology/pharmacology, clinical development, clinical operations and regulatory affairs to integrate translational biomarker and mechanism of action insights into overall drug development strategies.. M.D or Ph. D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or a related discipline.. Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models.
The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations.. Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.. Contribute to data review, interpretation and publication of clinical study results.. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods.. Should be board certified or equivalent in dermatology or allergy/immunology.
Provide internal and external consultancy on safety issues related to Pharmacovigilance and Patient Safety activities (processing safety and epidemiology reports, providing benefit-risk assessments, signal detection and investigations). Act as an expert to department and organization members regarding risk management, insurance, legal and regulatory matters. MD or an advanced degree in Pharmacy or Health Sciences (PharmD, PhD). Extensive professional experience in pharmacovigilance and clinical safety and understanding of clinical research development. Experience in clinical trials from CRO or pharma/biotech company or as an investigator
The Senior Director of Global Regulatory Affairs - CMC (GRCMC) leads and manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio.. Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes.. Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, acquiring global product registrations, and updating approved global product registrations for drug substances and drug products.. Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance.. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).