- 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
- Genmab (NJ)
- …(CT Gov.) site and status updatesPlans and Resource Management:Organize and track clinical trial documentation and reportsAssist in preparation of reports, ... trial operations.Experience in coordination and support activities for clinical trial conduct.Experience maintaining and tracking critical documentation… more
- Merck & Co. (Rahway, NJ)
- …& Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance ... Business Communications, Clinical Development, Clinical Research, Clinical Study Design, Clinical Trial Documentation , Clinical Trials, … more
- Eisai, Inc (NJ)
- …the pharmaceutical industry, with in-depth knowledge of TMF process and clinical documentation and eTMF system management.Requirements Bachelor's degree ... overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and… more
- Merck & Co. (Rahway, NJ)
- …and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of ... position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.The… more
- Aequor (South San Francisco, CA)
- …of time in the office (49% Homeoffice allowed) Job title Global Clinical Materials Manager Department PTDS-Global Competency Center Production Enablement Reports to ... Head Global Clinical Materials Management Locations SSF1. Duties and Responsibilities, Interfaces...products at material and batch level including the associated documentation Confirm the quantities received to enable accurate cost… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the end-to-end delivery of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Merck & Co. (Rahway, NJ)
- …& Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance ... with public disclosure of clinical trials and their results. The Senior Informed Consent...the principles of health literacyCollaborates with protocol authors and clinical teams to ensure comprehensive understanding of required timelines,… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, and specialty dosage forms.- Positions… 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
- 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
- Aequor (Thousand Oaks, CA)
- …Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication skills Values continuous ... Job Details: This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Merck & Co. (Boston, MA)
- …with external vendors of predictive and modeling and simulation tools supporting pre- clinical and non- clinical development, and data to assess opportunities and ... approaches for accelerating drug discoveryCreate and maintain the required documentation including Software Development Lifecycle (SDLC) deliverables (GxP and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …line functions. Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including data management, ... statistical programming, digital technologies, and clinical operations.Design and implement a fit-for-purpose organization responsible for operational and technical… more
- Merck & Co. (North Wales, PA)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... submissions including analysis/modeling datasets, tables, listings, figures and associated documentation .Ensure programmatic traceability from data source to analysis/modeling result.Maintain… more
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