- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...& Data Ops for EDC, edit checks, data quality listings, SAP, Data … more
- Novo Nordisk Inc. (WA)
- …The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in one or more of the following is preferred: Market Research, Data & Analytics, Clinical OperationsPharmaceutical industry experience helpful, but not ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Merck & Co. (North Wales, PA)
- …of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills: Strong ... analysis and reporting deliverables for Research & Development (R&D) projects ( data , analyses, tables, graphics, listings). Clinical Data Interchange… more
- Merck & Co. (Rahway, NJ)
- …to quality , compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; ... systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine… more
- Merck & Co. (North Wales, PA)
- … to develop innovative solutionsEnsure data science investments are maximized by data -driven initiatives, data quality and governance, data access, ... late-stage clinical trials across therapeutic areas around the globe.The Associate Director, Advanced Analytics will work with our partners across GCTO to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Writing is a key role responsible for producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines. ... position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Writing is a key role responsible for producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines. ... position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Aequor (Thousand Oaks, CA)
- …consistent basis. Job Details: Under minimal supervision, manage demand and supply of Pre- Clinical and Phase I Clinical Programs. The position requires project ... Responsibilities will include gathering demand requirements and driving production of Pre- Clinical and Clinical Investigational products, as well as tracking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Merck & Co. (North Wales, PA)
- … Data Management & Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered with high ... quality to meet the needs of our Research &...data standards and platform governance. Primary Responsibilities: Ensures Clinical Data Management products and services are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Associate as part of the Technical Operations team based in Raritan, NJ.Role ... scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other affiliates. ... 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
- 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …area readiness activities/processes, aiming to support start of a personalized clinical cell therapy site meeting cGMP requirements. This individual will serve ... ERP troubleshooting. In addition, will develop performance monitoring indicators, maintain data integrity of inventory records, and will assist with utilization and… more
