- U of C NORC (Bethesda, MD)
- …program and policy projects, with an emphasis on those related to pharmaceutical drug pricing practices and costs.NORC recognizes that talented and skilled ... expert team includes social scientists that acquire, collect, and analyze data from health care organizations and patients; evaluators; health services researchers;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …review and forecasting Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team ... difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a...study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks… more
- Merck & Co. (North Wales, PA)
- …alignment with the protocol.Minimum education required: Bachelor's Degree +2 years of pharmaceutical , clinical drug development, project management, and/or ... medical field experienceOR Master's Degree +1 year of pharmaceutical , clinical drug development, project management, and/or medical field experienceDegree in… more
- Merck & Co. (North Wales, PA)
- …technical writing, and presentation skillsEducation/Experience: Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management, ... and/or medical field experience OR Master's Degree +3 years of pharmaceutical , clinical drug development, project management, and/or medical field experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide medical and scientific input to Marketing/Market Access departments as needed Project management liaison: Assist in developing clinical program time ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (North Wales, PA)
- …application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within ... Clinical Monitors, Regulatory, Early/Late Development Statistics, Statistical Programming, Data Management, and our company's Research Laboratories Scientists in… more
- Novo Nordisk Inc. (Irvine, CA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Merck & Co. (North Wales, PA)
- …application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within ... particularly in meta-analysis and bayesian methodologies.Solid knowledge of- statistical and data processing software eg SAS and/or R.-Good project management… more
- Merck & Co. (Rahway, NJ)
- …of administration. This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the ... should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations, Non- clinical ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk and medical interactions with authorities. In addition, the responsibilities include clinical validity and medical integrity of data in Novo Nordisk ... R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best...programs including evaluation and interpretations of safety and efficacy data generated in the clinical trials and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently or through direction of a team of GLLs, manage, develop prepare and ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines, working from the discovery ... health.- In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix… more
- Merck & Co. (North Wales, PA)
- …years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management etc.) in the pharmaceutical industry, and 3 years SAS ... years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management etc.) in the pharmaceutical industry, and 3 years SAS… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface ... development, generation of experimental designs, execution experimental plans and data analysisDrives evaluation of new technologies and leads capability build… more
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