- Merck & Co. (Rahway, NJ)
- …technical writing, and presentation skillsEducation/ExperienceBachelor's Degree +9 years of pharmaceutical , clinical drug development, project management, ... and/or medical field experienceOR Master's Degree +6 year of pharmaceutical , clinical drug development, project management, and/or medical field experienceOR… more
- Merck & Co. (Upper Gwynedd, PA)
- …Position Qualifications : Education Minimum Requirement: Bachelor's Degree +1 years of pharmaceutical , clinical drug development, project management, and/or ... Specialist may be responsible for but not limited to:Job ResponsibilitiesMaintain clinical trial files (including eTMF), project processes, tracking systems,… 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
- 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. (WA)
- …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. (Rahway, NJ)
- …cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory, metabolic, ... Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical ... and leads clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents from the translational perspective. Provide translational deliverables (eg data , reports, and communications) to the Global Project Team ... 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)
- …Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. ... 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)
- …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)
- …labs or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/ Clinical BiomarkersSupport ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at Daiichi Sankyo.- Lead and manage the teams responsible for accurate disclosure of data and clinical information regarding all products at Daiichi Sankyo as ... clinical /research/academic experience, preferred- 10 or More Years of pharmaceutical industry experience in Medical Affairs, strategically utilizing scientific … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
