- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key… more
- Eisai, Inc (Nutley, NJ)
- …sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating ... will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA-approved… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift ... requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.Knowledge of cGMP regulations ... systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Eisai, Inc (Phoenix, AZ)
- …promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and management ... decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product access… more
- Mount Sinai Hospital (New York, NY)
- …and all other resources. 5. Documents in an accurate and thorough manner in compliance with hospital , regulatory and legal requirements and standards of ... Job Description The Clinical Nurse is a Registered Professional Nurse who...patient care including teaching, rounding, coaching, and planning after hospital care and delegating to others as appropriate. 6.… more
- Mount Sinai Hospital (New York, NY)
- …supplies and all other resources. Documents in an accurate and thorough manner in compliance with hospital , regulatory and legal requirements and standards ... Job Description Job Title: Clinical Nurse-MedSurge-Stepdown-10W-Mount Sinai Hospital -PT/Days The ...studies. Contributes to quality and safety practices and required compliance measures. Implements principles of high reliability to identify… more
- Children's National Hospital (Washington, DC)
- …growth and development and enhance quality improvement initiatives and regulatory compliance through seminars, workshops, and professional affiliations ... day-to-day research program operations following Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory guidelines, company goals,… more
- Mount Sinai Hospital (New York, NY)
- …resolution of potential safety hazards and validation of compliance with hospital and departmental policies and procedures and regulatory agency standards. ... operations of the Department of Nursing and all assigned clinical programs, which includes overall strategic planning for all...about progress, changes and compliance with all hospital policies and procedures and regulatory agency… more
- Phoenix Children's Hospital (Phoenix, AZ)
- …reaction, and controlled substance documentation reports and records to ensure ongoing compliance with quality and regulatory requirements and standards. a. ... Arizona State Board of Pharmacy and Phoenix Children's. This position also ensures compliance with Federal, State, and local laws and regulations as well as proper… more
- Lifespan (Providence, RI)
- …volume, beyond use date, and labeling. Performs sterile compounding and maintains compliance with regulatory boards and regulations related to compounding of ... (NIOSH) recommendations and Brown University Health policies and procedures. Maintains compliance with regulatory boards and regulations related to compounding… more
- Atlantic Health System (Morristown, NJ)
- …and Compliance : Performs and oversees data collection and documentation in compliance with SOPs and GCPs. Facilitates/collaborates with regulatory staff on ... assessments on study participants as needed Assume responsibility for assuring that clinical trials are conducted according to Good Clinical Practices guidelines… more
- Seattle Children's Hospital (Seattle, WA)
- …and staff development to meet current and anticipated needs and to maintain compliance with patient safety and regulatory requirements. 4-10 hour evening shifts ... Collaborate with Director, Clinical Director, Physicians and clinical staff...and Idaho - the largest region of any children's hospital in the country. US News & World Report… more
- Mount Sinai Hospital (New York, NY)
- …preparing clinical reports of assigned projects for submission to regulatory authorities. Performs other duties as required. Qualifications Bachelors Degree in ... Job Description The Clinical Research Associate I monitors all aspects of...master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs. Participates,… more
- UofL Health (Louisville, KY)
- …body mechanics, providing nutritional support and other activities as appropriate to clinical service, in accordance with hospital standards, nursing standards ... and external regulatory standards including the code of conduct Maintains compliance with all company policies, procedures and standards of conduct Complies with… more
- Community Hospital of Huntington Park (Huntington Park, CA)
- …obtain and improve knowledge on current policy and procedures, current nursing practice, regulatory changes, and hospital changes. Participates in hospital 's ... nursing competencies in collaborations with Directors. Is responsible for providing clinical and management leadership in patient care. Actively and consistently… more
- Mount Sinai Hospital (New York, NY)
- …teams using the principles of high reliability. Reviews unit progress, changes and compliance with quality and safety metrics with clinical nurses and other ... collaboratively with physician dyads and the healthcare team to promote patient care and regulatory standards. Maintains a nursing unit in compliance with all … more
- Cedars Sinai (West Hollywood, CA)
- …purpose. The database is also used to monitor subject participation, assure regulatory compliance and to manage inventory. Collectively, MIRIAD's capabilities ... sample preparation and shipping, and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Ensures … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, ... external auditing and study monitoring visits. Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.… more
