- Insmed Incorporated (Bridgewater, NJ)
- …- BS Degree required or preferred. A minimum of 8 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of ... chain including the Quality Management System, manufacturing, quality control, warehouse, and clinical operations. The...working in a GxP regulated industry and preferably in quality assurance role. Experience as QA reviewer… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance , the Senior Director of Pharmacovigilance QA ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices… more
- Merck & Co. (Rahway, NJ)
- …in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance , Finance, Regulatory, Clinical Supplies and legal ... Job DescriptionOur Clinical Research and Pharmacovigilance team push... clinical audit outcomes, working closely with the Quality Assurance group and the Good … more
- Catalent (St. Petersburg, FL)
- …maintains communication and collaboration with various departments such as product development, quality control, safety, metrology, quality assurance and ... approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.The Analytical Laboratory Clerk, Research and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and implement ... ResponsibilitiesProvide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for… more
- Insmed Incorporated (Bridgewater, NJ)
- …prior to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for ... purchase orders, payment tracking and process for external parties.Strong knowledge of clinical research process, including working knowledge of all functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on study and project teams. This position requires significant understanding of clinical research for drug development, from hypothesis formulation to subject ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Affairs to align study with health authority requirements; with Quality Assurance to guarantee subject safety and… more
- Eisai, Inc (NJ)
- …service provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and ... and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional service providers… 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 ... holder through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable… more
- Merck & Co. (Rahway, NJ)
- …of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position ... anticipate stakeholder requirements.Preferred Experience and Skills: Demonstrated success in the assurance of deliverable quality and process compliance. Strong… more
- Merck & Co. (North Wales, PA)
- …safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... statistical analysis and high- quality data to assist decision making in ...statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.… more
- Nesco Resource (West Jefferson, OH)
- …quality requirements and client specificationsPrepare and submit study files and forms to Quality Control or Quality Assurance . o Recognize when technical ... JOB SUMMARY s Biomedical Research Center is currently seeking an In-Vitro Assay/Microbiology...from in vivo pathogenicity/efficacy/toxicity studies as well as human clinical samplesSome assays include: bacterial enumeration, viral assays, ELISA,… more
- Merck & Co. (Rahway, NJ)
- …safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... statistical analysis and high- quality data to support decision making in ...requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance.… more
- Merck & Co. (North Wales, PA)
- …engage key stakeholders.Demonstrated success in the assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … clinical manufacture or NPI is preferred. Experience in clinical quality , method development, cell banking, or Research & Development is preferred. ... with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality Control and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research , ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Deliver the… more
- Merck & Co. (Rahway, NJ)
- …to engage key stakeholders also required.Must possess demonstrated success in the assurance of deliverable quality and process compliance; and strong working ... and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose… more
- Merck & Co. (Rahway, NJ)
- … quality .Collaborate with cross-functional teams, including operations, maintenance, and quality assurance , to identify areas for improvement and implement ... and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities. In this role, you will be responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risks and operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Drive medical… more
- Tris Pharma (Monmouth Junction, NJ)
- …reportsLiaises, coordinates and manages early development activities with external labs and Clinical Research Organizations (CROs) and Clinical Development ... and reviews PD Standard Operating Procedures (SOPs), as neededCollaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive… more
