- Merck & Co. (Rahway, NJ)
- … research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of...clinical trial processes as well as quality management systems and quality control tools.Expert knowledge of GCP/ICH and… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality...skills Experience with GxP systems including computer system validation and associated regulations, recommended.… more
- Merck & Co. (Rahway, NJ)
- …drive delivery of high-quality datasets. Monitor the flow of data between complex clinical data systems and the processes surrounding that data, drive creation ... processes for data flow, analysis and storage across the company's systems . 10% domestic travel required.LOCATION:126 E. Lincoln Ave., Rahway, NJ 07065REQUIREMENTS:… more
- Merck & Co. (North Wales, PA)
- …Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:CDISC ADaM, Clinical Testing, Database Management Systems (DBMS), ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Insmed Incorporated (San Diego, CA)
- …This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency ... and efficient processes in the implementation and integration of patient data systems . The candidate will collaborate closely with the Biometrics teams, Clinical… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution ... of the global Clinical Quality Assurance (CQA) strategy including audit and inspection.../CQA conducting a broad range of audits.Experience with GxP systems including general knowledge of CSV and associated regulations.Proven… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Merck & Co. (Upper Gwynedd, PA)
- …BS degree required, focus in Data Science, Computer Science, Management Information Systems or relevant clinical domain degree preferred. Required Experience and ... Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the development of analysis,… more
- Aequor (Thousand Oaks, CA)
- …communicate decisions concerning distribution complaints. Sales Order Management: - Create and manage clinical drug shipments in ERP systems (eg, SAP) - Generate ... Emergency Coverage: Must be able to report onsite if systems go down and manual processes required. Experience with...long-term stability. Associate Supply Chain Description: As an Associate, Clinical Supply Chain, you will play a key role… more
- Insmed Incorporated (San Diego, CA)
- …risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Must be able to foster a collaborative environment, adapt to other ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Cincinnati, OH)
- …RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D).--Primary Activities:Identify, establish and manage ... collaborative professional relationships with national, regional and clinical practice scientific leaders (SLs) and investigators to identify and address scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional ... management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP… more
- Eisai, Inc (Atlanta, GA)
- …from you. : The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ABL ... sales goals, and coaching Sales Representatives on critical selling skills, clinical expertise and business acumen. Responsibilities: Develop and implement sales… more
- Merck & Co. (Rahway, NJ)
- …The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation ... connection and collaboration within and across teams and functions.-The NGB GMP clinical manufacturing building will be a new entirely single-use facility, and this… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Formation Bio (New York, NY)
- …and product teams to transition proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome ... 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
- Merck & Co. (North Wales, PA)
- …These projects can be cross divisional and relate to optimizing PM capabilities, systems , and operations (e,g., leading efforts to improve planning systems ... given projects; is business savvy and results oriented -Working knowledge of clinical drug development, with relevant experience that informs fluent understanding of… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
