- Eisai, Inc (Nutley, NJ)
- …collating information and providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices. Act as central ... clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and… 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
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Executive Director, Global Clinical Development resides within the Oncology at Eisai. This Executive Director will lead ... franchise programs, and will be the clinical group leader for the ongoing and planned development...Phase II and Phase III studies, and prepare related documentation for submissions.This position will lead a development team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, ... treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API ... manufacture and/or regulatory inspections. Independently performs audits of batch documentation , data, information, procedures, equipment and systems , and/or… more
- Merck & Co. (Rahway, NJ)
- …activities.- Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP ... Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide expertise ... qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment,… more
- Merck & Co. (Rahway, NJ)
- …& Development team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical devices/drug ... delivery systems . Reporting to the Director responsible for this area,...semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert,… more
- Aequor (Athens, GA)
- …in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation ... enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems , and livestock handling equipment. Performs cleaning and sanitation of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy ... requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to… more
- Eisai, Inc (Raleigh, NC)
- …with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation , and reporting of quality goals ... a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This position is responsible… more
- Genmab (NJ)
- …join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Formation Bio (New York, NY)
- …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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Insmed Incorporated (Los Angeles, CA)
- …assigned budget parametersIs accountable for the accurate and timely documentation of all activitiesIdentify Medical Experts, consultants, investigators, and ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Bring together, synthesize and deliver HCP derived… more
- Aequor (Thousand Oaks, CA)
- …as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected to ... vital to the impact that ATO B20 with a clinical and commercial product mix has to the network....functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when… more
- Merck & Co. (Rahway, NJ)
- …and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical ... foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation , ensuring all processes align with our company's expectations.Mentor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... on time in a manner consistent with safety policies, quality systems , and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, Engineering, and… more
