- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy.GxP Quality ... and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other ... for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical … more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy.Knowledge of cGMP ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Merck & Co. (North Wales, PA)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... Outcomes, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance , Clinical Trial Management, Communication, Data… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Rahway, NJ)
- …protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and ... Operations, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance , Clinical Trial Management, Clinical… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Eisai, Inc (Nutley, NJ)
- …the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This ... company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across… 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....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Merck & Co. (Rahway, NJ)
- …Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to ... global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality … more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling ... of clinical and developmental supplies for sterile products, including critical...and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
