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ProKatchers is seeking a travel nurse RN Quality Assurance for a travel nursing job in Novato, California. Posted job title: (RN) - Quality assurance.. Founded in 2016, ProKatchers Inc. is a JCC-certified organization and a recognized leader in healthcare staffing. Named one of the Fastest Growing Healthcare Staffing Firms by Staffing Industry Analysts (SIA) for 2023–2024, we are proud to be among the top-rated companies in our industry. We specialize in placing clinical and allied health professionals in a wide range of healthcare settings, including acute care hospitals, skilled nursing facilities, long-term care centres, rehabilitation facilities, behavioural health canters, home and community health programs, urgent care clinics, and more.
This leadership position is ideal for a Registered Nurse with a strong background in hospice or palliative care and a passion for ensuring patients receive exceptional, empathetic end-of-life care.. Team Management: Recruit, train, mentor, and supervise clinical staff including RNs, LVNs, social workers, and home health aides.. Regulatory Compliance: Maintain compliance with Medicare/Medicaid guidelines and accreditation standards; manage documentation and audits.. Cross-Department Collaboration: Work closely with social services, spiritual care, and administrative departments to provide comprehensive care.. Experience: Hospice or palliative care, with at least 2 years in a leadership role.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area.. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
We are passionate about advancing scientific discoveries to become important medicines for rare disease patients.. The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development.. Experience with regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities).. Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities. Traumatic brain injury
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, protocols, CSRs, INDs/ CTAs, and marketing applications.. Experience in oncology drug development is preferred.. Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure’s, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.. Strong analytical skills; ability to understand and interpret complex clinical and scientific data and formulate those data into a well-thought out and reviewer friendly manner.. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FRα)-targeting ADC in clinical studies.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department.. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports.. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics.. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology.. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.. Clinical Studies -Able to mentor or train others in clinical study concepts, design, and documentation -Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.. -Advanced applied knowledge of: o documentation required for the conduct of clinical studies o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) o study results reporting o integrated results reporting -Direct experience with documentation in all phases of drug development.. o Interpreting data from tables, graphs, and listings o Creating in-text data presentations (including complex tabular and graphical clinical data presentations) o Interpreting basic clinical laboratory tests o Researching literature o Understanding concepts of coding dictionaries (MedDRA, WHO Drug) o Preparing high-quality clinical and regulatory documents (protocols, IBs, clinical study reports, ICFs).. Experience using document management software (e.g. SharePoint, Veeva)
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.. This Regulatory Affairs Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Company Summary: A pre-IPO clinical stage biotech developing revolutionary therapies in the oncology & CNS spaces.. The Opportunity: Our client is seeking a seasoned physician with a strong clinical background and a passion for drug development to join our Clinical Development team where they will serve as the Senior Director, Clinical Research, Oncology.. Working closely with biomarker, discovery, and translational research scientists.. Collaborating closely with Clinical Science and other relevant functions and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.. Working closely with functional partners (Data Management, Clinical Operations, Biostatistics, Regulatory) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in clinical development in close collaboration with key functional stakeholders.
The Clinical Research Associate (CRA) will manage clinical aspects of a small to medium-sized clinical study or, with supervision, assume some management responsibilities on a large-scale study.. Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.. Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.. Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits.. A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
This approach promotes productivity, supports work-life integration, and ensures essential face-to-face onboarding and skill development.. The Medical Director will be responsible for utilization review case management for Medicare and Medicaid in the California market while also assisting in the Washington Medicaid market.. Unless expressly allowed by state or federal law, or regulation, must be located in a state or territory of the United States when conducting utilization review or an appeals consideration and cannot be located on a US military base, vessel or any embassy located in or outside of the US.. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer.. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.. Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine, preferably in hematology/oncology.. Prior experience with UCSF, particularly with research in the oncology setting, clinical trial billing, and institutional policies for study compliance and regulation.. The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
Employee Assistance Program (EAP) including free counseling and health coaching.. We offer ongoing training and development opportunities for licensed and unlicensed healthcare team members, and have best in class clinical resources for training, education, and point of care support. The Assistant Director of Nursing (ADON) is responsible for managing and supervising the nursing staff and operations of the facility to ensure that patients receive appropriate healthcare services. The ADON also ensures compliance with regulatory guidelines and maintains a safe and healthy environment for patients and staff. Regulatory agency knowledge including The Joint Commission, DHSS, Centers for Medicaid/Medicare Services is preferred.
Hybrid Work ArrangementThe Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine.. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.. We seek a Cancer Clinical Research Coordinator 2 to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.. Reporting to the Early Drug Development Clinical Research Manager, the Cancer Clinical Research Coordinator 2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to provide leadership within the clinical research team.. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.
Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors.. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.. Experience working with Medidata Rave. Experience using standardized medical terminology, including MedDRA and WHO Drug. Principal Data Manager - Clinical Data Quality Leader Senior Manager, Clinical Data Management Associate Director, Clinical Programming Alameda, CA $179,500.00-$255,500.00 1 week ago
We're looking for an RN Patient Care Manager to join our team.. You will report directly to the Executive Director, Administrator, or Senior Patient Care Manager.. At least three years’ experience of direct patient care and two years’ experience in hospice or home-based care setting. Demonstrates knowledge and compliance with accepted hospice principles and practice, including industry standards, regulations, and best practices (i.e., Medicare, Medicaid, JCAHO, ACHC), company policies/procedures, and understanding ofterminally ill patients and their families. Company: Heartland Hospice
Location Heartland Hospice. At Heartland Hospice, part of Gentiva, it is our privilege to offer compassionate care in the comfort of wherever our patients call home.. We are a national leader in hospice care, palliative care, home health care, and advanced illness management, with nearly 600 locations and thousands of dedicated clinicians across 38 states.. Hospice care: Gentiva Hospice, Emerald Coast Hospice Care, Heartland Hospice, Hospice Plus, New Century Hospice, Regency SouthernCare, SouthernCare Hospice Services, SouthernCare New Beacon. Palliative care: Empatia Palliative Care, Emerald Coast Palliative Care
Associate Director, Regulatory Affairs - Global Labeling page is loaded. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area.. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.
Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors.. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.. Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation.. Experience working with Medidata Rave. Experience using standardized medical terminology, including MedDRA and WHO Drug.
Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors.. Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.. Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation.. Experience working with Medidata Rave. Experience using standardized medical terminology, including MedDRA and WHO Drug.