- Merck & Co. (Rahway, NJ)
- …clinical trials.Required Skills: Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance , Clinical ... Job DescriptionOphthalmology Clinical Scientist:Job SummaryThis position leads the scientific planning and execution of one or more clinical trials or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alignment across all functions and sites.Support the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support ... in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.Knowledge of cGMP regulations… more
- Eisai, Inc (Nutley, NJ)
- …organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing ... a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Insmed Incorporated (NJ)
- …and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidanceSupport Clinical Supply Chain to ensure compliance with eTMF documentation ... the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and… more
- University of New Mexico - Hospitals (Albuquerque, NM)
- …Cystic Fibrosis Foundation (CFF). The RN Coord Cystic Fibrosis position ensures clinical compliance with the CF Foundation's mandates, including registry ... RN Coord Cystic Fibrosis position plays a critical role in supporting the clinical and programmatic operations of the Cystic Fibrosis (CF) Center. Working in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through ... an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, technical operations or cell therapy.Experience… more
- Eisai, Inc (NJ)
- …to drive innovation and operational efficiency.Partners with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing ... is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of outsourcing strategies… more
- University of New Mexico - Hospitals (Rio Rancho, NM)
- …of optimal and safe patient care which includes fiscal management, standards compliance , clinical practice, staff development, oversight and active participation ... in clinical practice, and performance improvement activities that evaluate program...cost-effective utilization of products, services, processes and resources * COMPLIANCE - Ensure compliance with all regulatory… 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 ... over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting… 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
- 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 ... facilities within the United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be a key leader in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.GxP Quality System knowledge, ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.GxP Quality System knowledge, ... systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.Knowledge of cGMP and ... during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy. A portion of the ... technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Insmed Incorporated (NJ)
- …structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk ... program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trials Operations, Computer Science, Design, Detail-Oriented, Ethical Compliance , Ethical Standards, GLP Regulations, Good Clinical Practice (GCP), ... and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy.GxP Quality System knowledge, ... change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Merck & Co. (MA)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a ... focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of appropriate… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in ... myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe are… more
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