- 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
- 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 ... programs, clinical trial processes as well as quality management systems and quality control tools.Expert knowledge of GCP/ICH and worldwide Regulatory Health… 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
- 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
- Merck & Co. (Upper Gwynedd, PA)
- …Requirement:- BS degree required, focus in Data Science, Computer Science, Management Information Systems or relevant clinical domain degree preferred. ... Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the development of analysis,… 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
- 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
- Merck & Co. (Cincinnati, OH)
- …- Virology RMSDs provide Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to our Company and responds ... RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D).--Primary Activities:Identify, establish and manage… more
- BioAgilytix (Durham, NC)
- …to add/move/change user accounts and workstations; addresses issues with corporate systems such as printers, phones, and audio-visual (AV) equipment; and supports ... related to the overall corporate infrastructure and validated computerized systems .Essential Responsibilities Prioritize and respond to end user service requests… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information , and product data.Demonstrate full knowledge of and… more
- Eisai, Inc (Nutley, NJ)
- …programs, and utilize clinical expertise to present product and disease state information to new Sales hires. Contributing to reports on Medical Information ... If this is your profile, we want to hear from you. The Sr. Medical Information Specialist is responsible for meeting the medical information needs of internal… more
- Merck & Co. (North Wales, PA)
- …Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... understanding of how countries' medical systems and standards of care need to change to...relevant members to the Product Development sub-teams (Value Evidence, Clinical , Commercial, Publications and Label teams)Aligns medical plans and… 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
- 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
- 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)
- …of Science in a related discipline (eg, Chemistry, Pharmaceutical Sciences, Data Analytics, Information Systems ),- with a minimum 4 years of experience- - ... Master's degree in a related discipline (eg, Chemistry, Pharmaceutical Sciences, Data Analytics, Information Systems ),-- with a minimum of 3 years of experience… 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 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
