- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or ... with-ICH/GCP and country regulations, Our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the… more
- Novo Nordisk Inc. (Atlanta, GA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and strategies Implements… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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 ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… 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
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) ... of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors ... and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA ... Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Merck & Co. (North Wales, PA)
- …process owners in GCD and GCTO like our company's IT, Medical Monitors, Clinical Scientists, Clinical Quality Operations Managers (CQOMs), GDMS, BARDS ... of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our...in clinical research (eg, monitoring, data management, clinical quality assurance, study management)Experience with risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the ...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Technician, OperationsPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … more
- Merck & Co. (North Wales, PA)
- … quality , compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate , Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... or support client audits along with the Director and Associate Director of Quality AssuranceManage a direct...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Aequor (South San Francisco, CA)
- …the mechanisms underlying toxicities that are observed non-clinically and/or in clinical trials through hypothesis driven research. This process involves closely ... safety assessment for our Client therapeutics spanning drug discovery through clinical development and marketing. The group provides fit-for-purpose wet lab-based… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
