- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Clinical ... data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... to ensure business objectives are metManages and monitors organizational compliance with all established supplier agreementsProvides strategic procurement partnership:Assists… more
- Eisai, Inc (NJ)
- …and management. Collaborates with study teams, legal, finance, clinical planning, compliance , clinical quality , data protection, IT security and other ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... and metrics. Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… 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....you ready to make a difference? The Position The Manager , Digital Transformation will drive execution of Novo Nordisk,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , MSAT or cell therapy. A portion ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ.… more
- Eisai, Inc (Exton, PA)
- …Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications ... (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific backgroundIdentifies CMC regulatory issues and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Merck & Co. (Minneapolis, MN)
- …across a portfolio of our Company products-Ensuring proper oversight and compliance with our Company policies and exercising appropriate financial stewardship IAL ... business review of account performance to optimize net sales for our Company Clinical : Communicate to customers the clinical value proposition for assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/ compliance Plan, oversee, coordinate ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/ compliance Updates… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions...failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing… 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 ... with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical… more
- Aequor (Thousand Oaks, CA)
- Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit to support site operations once a week to once a month depending ... consistent basis. Job Details: Under minimal supervision, manage demand and supply of Pre- Clinical and Phase I Clinical Programs. The position requires project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality support in clinical manufacture or NPI is preferred.Experience in clinical quality , method development, cell banking, or Research & Development is ... Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Rakuten Medical Inc. - US (San Diego, CA)
- …inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee ... Summary Reporting to the Chief Technology Officer, the Senior Manager /Associate Director of Clinical GCP Quality...11 compliance is a plus. Experiences with Clinical Quality Management on a risk-based approach… more
