- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for… more
- Merck & Co. (Boston, MA)
- …drug candidates.Perform technical and trend analysis of the data and communicate data to project teams and functional management .As part of our Company's ... conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our...team in Boston, MA is seeking a highly motivated Senior Scientist for a lab-based role with creative passion… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Merck & Co. (North Wales, PA)
- …communication skills (written and oral) in addition to results-oriented project management skills Preferred experience and skills: Deep clinical expertise ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers...as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior...or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary ... continuity of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP,… more
- Merck & Co. (Rahway, NJ)
- …must have experience in executing complex study designs requiring highly organized data collection and management . The selected candidate will be expected ... the departmental move to Rahway, NJ will be communicated at a future date. Senior Scientist, Process Cell Sciences (PCS) at Kenilworth, NJ - The Biologics Process… more
- Merck & Co. (Rahway, NJ)
- …how to appropriately raise issues and drive discussion within peer groups and with senior management .-Demonstrated courage of conviction - able to speak up / ... contribute to all circles; comfortable challenging ideas or proposals, including senior management .-Brings forward creative ideas and contributes to setting… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Eisai, Inc (Nutley, NJ)
- …monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and validation ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...efforts of Translational Science to generate useful human biomarker data sets from internal (eg clinical samples,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the ... of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Merck & Co. (Rahway, NJ)
- …risks. Leveraging this valuable insight, you will provide feedback to senior management and drive continuous improvement initiatives.Quality Improvement ... Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and...inspections. Your expertise and guidance will ensure the smooth management , training, and support of regulatory Health Authority inspections,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... for the therapeutic area. Communicate and represent these plans to upper management / senior leadership. Continuously update plans and inform stakeholders of… more
- Novo Nordisk Inc. (Boulder, CO)
- …network performance for data capture and analysis locally and globally. The Senior IT Engineer I - Labs will therefore be working closely with research and ... the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future,...you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... stakeholders.Position Specific Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) ... Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution and ... Operations (shipping, receiving, inventory control, customs clearance, supply / device management ) Responsible to ensure timely availability of clinical study… more
