- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical ...as quality lead on the gene therapy clinical development team, and collaborates on other related activities… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines.… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full c ompany's Research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (North Wales, PA)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and ... scientific -pl anning and execution of one or more clinical trials or significant aspects thereof . In this...Job Responsibilities - Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s) . This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Eisai, Inc (Nutley, NJ)
- …the clinical operations function in the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good ... clinical operations activities. These activities directly impact the timeliness, quality , and successful execution of clinical studies in accordance with… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research & Development… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement ... audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.ResponsibilitiesSupport audit… more
- Formation Bio (New York, NY)
- …efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to ... will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within R&D and cross-functionally, to facilitate, roll-out and track… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....a difference? The Position Position is responsible for developing Quality and USO strategic objectives and strong business understanding… more
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