- Merck & Co. (Rahway, NJ)
- …products to produce safe, effective, innovative medicine.We are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can ... Success - They are a Competitive Advantage for UsSummary, Focus and PurposeThe Clinical Operations Manager - Regulatory is accountable for achievement and… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... Clinical Research and Pharmacovigilance team push the boundaries of...for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... for assigned protocols and sites in a-country.-Under the oversight of the CRA manager or CRD, the person ensures compliance of study-conduct with ICH/GCP and country… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Option Care Health (Columbus, OH)
- …always. Naven Health is a nationwide home infusion nursing network and clinical platform focused on delivering specialized, truly exceptional infusion care. With ... services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining the Naven… 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 ... systems records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement , error… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Validation with the goal of creating a culture shift to data-driven data quality . This position requires working knowledge of clinical data management processes, ... strategy. This role will assist in driving the connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk Quality Management System as well as supporting continuous improvement projects within the department, affiliate, and/or in collaboration with global ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Catalent (Manassas, VA)
- …site and across the company. Leads site-level initiatives for supplier management, supplier quality & supplier performance improvement as well as supports global ... help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …[QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure ... and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement ...in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand-level marketing ... and other materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality control of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tasks at all times Provides strategic input and contributes to process / quality improvement initiatives Guides the successful completion of major programs or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …timeline and KPIs, overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant. Serve as the ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manager /Sr. Manager , External Manufacture as part of the Technical Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Catalent (Manassas, VA)
- …the computer to enter and track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and ... Specialist - 2nd Shift is responsible for creating and maintaining the Quality System documentation. Communicate any deviations to management. Assist the Quality… more
- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying… more
