- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies:… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to ... role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research Associate)- Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational… more
- Merck & Co. (Rahway, NJ)
- …Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt...experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality… more
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... services/tasks in support of the planning and execution of quality driven clinical trials in line with... clinical trials Demonstrated computer skills (MS Office, clinical trial systems ) and adaptability to new… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... & deliver all relevant services/tasks in support of the design, planning & quality * delivery of clinical trials (including required staffing, training &… more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... Manager , QA (Product Development)Position SummaryThe Quality ...support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit/inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Aequor (NJ)
- …development studies during phases 1-4. The individual must partner closely with clinical , regulatory, quality and production associates to ensure timely delivery ... 100 % remote Manager prefers local candidates (will consider non local...third party vendors to ensure the timely, efficient, high quality , cost effective execution of all outsourced clinical… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality...of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems … more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the ... research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , MSAT or… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... 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… more
