- Novo Nordisk Inc. (Plainsboro, NJ)
- …processing activities, which include the receipt, documentation, triage, case review, and quality assessment of all inbound safety information, including serious ... of periodic and annual reports for submission to the FDA Monitor the quality of Product patient Safety deliverables and provide ongoing feedback regarding… more
- Merck & Co. (Rahway, NJ)
- …as quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.Experience ... into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including… more
- Tris Pharma (Monmouth Junction, NJ)
- …analysis plans, informed consent forms, Clinical Study Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external ... cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety … 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...in making a difference. Catalent is committed to the health and safety of its employees, visitors… 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...in making a difference. Catalent is committed to the health and safety of its employees, visitors… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as ... a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... Senior Analyst will be the Master Data Management (MDM) primary Subject Matter Expert (SME) for Market Access and Public Affairs (MAPA), Pricing & Contracting… more
- Merck & Co. (Rahway, NJ)
- …bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the related smaller scale potent development ... lab startup. They will also become a subject matter expert for a Grade C lab in the facility.-The...closely with the development engineers & chemists, compliance representatives, safety partners and other team members to ensure the… more
- Merck & Co. (Durham, NC)
- …and process deviations as appropriate while notifying appropriate personnel. Serves on safety , quality and other committees as required. Actively participate on ... walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality , safety or environmental training/initiatives as required. Self-motivated to… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; ... most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with the… more
- Catalent (St. Petersburg, FL)
- …is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership...for improvement. Is expected to become the Subject Matter Expert for the client products, processes and requirements and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and accuracy of analysis results. Ensures timely delivery of high quality deliverables.- Global Health Authority Interaction / Negotiation: Authors ... This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO)...complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team… more
- Catalent (St. Petersburg, FL)
- …the health of the client relationship and state of quality systemstechnical Provide QA Technical recommendations based on trend analysis to eliminate ... QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg...in making a difference. Catalent is committed to the health and safety of its employees, visitors… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …members, and peers. Harmonize with Environmental, Health , and Safety personnel, Product Development, and Quality /Manufacturing personnel. Independently makes ... Quality risk assessment teams. Review/approve documents as a Quality on the Floor Subject Matter Expert ...a Quality on the Floor Subject Matter Expert (SME). Remain current in skills and industry trends.… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change ... management.Familiarity with US and EU GMP and Safety compliance regulationsEffective interpersonal and communication skills, both verbal and written.Excellent… more
- Taiho Oncology (New York, NY)
- …responsibility to engage in the exchange of scientific data, education of health care practitioners on Taiho products and relevant disease states, and facilitation ... Support to External Stakeholders: Acts as the primary clinical/scientific resource to Health Care Professionals (HCPs) in a specified geography for information about… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- CHRISTUS Health (Lindale, TX)
- …ethics, and regulations within the industry. Standard IV. Safe Practice/ Quality Care/Regulations Incorporates patient safety practices/guidelines to promote ... positive patient outcomes Demonstrates accountability for nursing research and quality improvement activities Provides evidence-based nursing care Communicates patient… more
- CHRISTUS Health (Tyler, TX)
- …ethics, and regulations within the industry Standard IV. Safe Practice/ Quality Care/Regulations Incorporates patient safety practices/guidelines to promote ... in positive patient outcomesDemonstrates accountability for nursing research and quality improvement activitiesProvides evidence-based nursing careCommunicates patient information effectively… more
- CHRISTUS Health (Tyler, TX)
- …on the operations, ethics, and regulations within the industry Safe Practice/ Quality Care/Regulations * Demonstrates accountability for nursing research and ... quality improvement activities * Provides evidence-based nursing care *...healthcare practices and activities Serves as a subject matter expert for patient care * Gives continuing feedback, recognizes… more
