- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational… more
- Merck & Co. (Rahway, NJ)
- …ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource ... DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for...partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of deliverables at… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business ... System [QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and ... 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 (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 ... room release, in-process and receiving inspections, and raw material/product sampling.Implement Global quality policies and standards and Catalent network… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… 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 ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the … more
- Merck & Co. (Rahway, NJ)
- …case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... leading global Publication Teams as well as driving the development...publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and… 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 ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role… 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
- Eisai, Inc (Nutley, NJ)
- …Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information ... reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for… more
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Catalent (Manassas, VA)
- Site Procurement ManagerPosition Summary Catalent is a global , high-growth, public company, and a leading partner for the pharmaceutical industry in the development ... 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)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... hhc ).Represent the brand with internal and external stakeholders, including Global and Regional colleagues. Ensure appropriate strategic direction is communicated… more
