- Merck & Co. (Rahway, NJ)
- …(Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging ... activities as well as supply chain documentation to support critical CMC activities ....supplies information at Investigator Meetings for assigned protocols. - Support the collection of clinical suppl y… more
- Merck & Co. (Rahway, NJ)
- …cost estimates requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging ... activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Insmed Incorporated (San Diego, CA)
- …by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their ... experience establishing and fostering compliance with ICH E6 Guideline for Good Clinical Practice.Provide support and coaching to other staff members to… more
- Merck & Co. (North Wales, PA)
- …Material(s):Required Skills:Business Development, Business Development, Business Management, Clinical Documentation , Clinical Investigations, ... Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation , Clinical Trial Planning, Consultative Approach,… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities ... and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and...providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations… more
- Merck & Co. (Rahway, NJ)
- …a secondary focus on FLEx Sterile2, currently in project phase via GES.- Provide support of the mechanical aspects of clinical operations, including support ... Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily… more
- Eisai, Inc (Exton, PA)
- …Functions 1. Oversee the operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase ... of Upstream and Downstream production staff in the operation of equipment to support preclinical and phase I to III clinical trials. Supervise change-over… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the organization and affiliates as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and ... business functions, internal and external stakeholders to execute audits effectively. Support inspection readiness by preparing clinical teams, Clinical… 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
- Merck & Co. (Rahway, NJ)
- …including analysis/modeling datasets, tables, listings, figures and associated documentation .Ensure programmatic traceability from data source to analysis/modeling ... result. Support the development of programming standards to enable efficient...field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer… more
- Insmed Incorporated (Los Angeles, CA)
- …managed markets/healthcare/payor systems, in addition to other unique healthcare influencers.Full support and execution of Medical Affairs plans, Clinical ... with external healthcare practitioners to provide comprehensive medical and scientific support for the therapeutic area of PAH/PH-ILD. This position will cover… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial ... individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and... the organization in its build and ramp-up of clinical production and facility approval of a state of… 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
- Merck & Co. (Durham, NC)
- …warehouse operations and efficiency.- Additional responsibilities will include qualification support of off-site warehouse facilities for ambient and -70 storage ... Logistics and Operations managers and personnel as a subject matter expert (SME) in support of training and implementation of any new projects.- This includes SME … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP ... qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment,… more
- Merck & Co. (Rahway, NJ)
- …drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline. Responsibilities: Under the scientific ... aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of… more
- Eisai, Inc (Raleigh, NC)
- …batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.Maintain associated documentation and records ... 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
- Merck & Co. (Rahway, NJ)
- …and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical ... biologics portfolio.Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments,… more
- Genmab (NJ)
- …us!The RoleThe 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
