- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …ready to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials Verifies safety reporting and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...the disease area and compound/DrugMay serve as speaker for program / franchise medical/scientific training - Guide the Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... initiation date.Release batch within scheduling database.Communicates SQDC countermeasures and safety issues to Quality Management.Ensures QADC metrics are… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors...Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and… more
- Catalent (San Diego, CA)
- …from the best. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... in Philadelphia, PA is hiring a QA Inspector. This position reports to the Quality Supervisor. The Quality Inspector is responsible for process monitoring and… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Document Control Supervisor Position Summary Catalent...a deep understanding and values around patient and employee safety , will assist in the enforcement of GMPs and… more
- Catalent (Manassas, VA)
- …if any out of specification or any deviations are found. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standard and any other standard that ... enter and track result data Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP)...of PTO + 8 paid holidays Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers… more
- Catalent (San Diego, CA)
- …from the best. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Associate II - Manufacturing Catalent Pharma...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… 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 ... within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and reporting of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/ Clinical Departments. The incumbent will ... Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Merck & Co. (North Wales, PA)
- …of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is ... quality , compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors ... perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Taiho Oncology (New York, NY)
- …and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources ... care practitioners on Taiho products and relevant disease states, and facilitation of clinical research. The Sr. MSL integrates clinical and scientific knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and ... for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project...ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality… more
- Taiho Oncology (TX)
- …on Taiho products and relevant disease states, and facilitation of clinical research. The MSL integrates clinical /scientific expertise and knowledge ... Product/Therapeutic Area Support to External Stakeholders: Act as the primary clinical /scientific resource to HCPs in a specified geography for information… more
