- Legend Biotech USA, Inc. (Raritan, NJ)
- …ad hoc, for activities such as annual product review, site risk register, or internal quality agreements. Develops and delivers training for specific quality ... audit process. Support the planning and execution of internal audits for all quality system areas...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Novo Nordisk Inc. (Stamford, CT)
- …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 ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO(s) provide timely input and generate documents in a timely manner and with quality (eg communication plan, site monitoring plan, etc.) as per study ... Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, ... Committee Meeting- Develop and maintain programming macros to effectively support internal data review and monitoring . Responsibilities include: work with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with applicable privacy laws and regulations; and (b) managing and conducting internal investigations. This position, working with DSI's Data Privacy Officer, will ... Sankyo, Inc. and its affiliate, American Regent, Inc. for conducting internal investigations. This position requires strong investigative skills, strong technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... personal and professional development. You will manage relationships with internal and external key collaborators, including Novo Nordisk affiliates. Additionally,… more
- Other Executive (Worcester, MA)
- …Ensures processes for viability of performance improvement programs. Identifies key quality indicators for monitoring and evaluating. Participates in the ... and internal benchmarks at board meetings). Monitors and evaluates quality through public reported measure (eg core measures, nurse sensitive patient outcomes,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …investigations, and process improvement projects.Identify, and oversee changes within quality systems.Assure equipment maintenance and calibration, and internal ... The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... training for pharmacovigilance as well as Safety training conducted for internal and external stakeholders. Coordinates project activities and needs related to… more
- Merck & Co. (Rahway, NJ)
- …performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.Performs Quality control visits as required.Leads ... with-ICH/GCP and country regulations, our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Merck & Co. (Rahway, NJ)
- …performance issues and training-needs to CRA manager and/or functional vendor and internal management as-needed.o Performs Quality control visits as required.- ... with ICH/GCP and country regulations,-our company's policies and procedures, quality standards and adverse event reporting-requirements internally and externally.The… more
- Merck & Co. (Rahway, NJ)
- …energy savings initiatives, improved reliability, operability and maintainability.-REES Environmental Monitoring System : The Rahway site utilizes a single ... environmental system (REES) to support the monitoring and alarming of multiple areas onsite included but not limited to areas for our company's Research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …programs Assists in the creation, tracking and completion of maintenance related quality events, CAPAs, and Out of Tolerance (OOT) situations Conducts basic risk ... on an EHS first mindset, a Right First-Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous improvement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders. Relationships This position will report to… more
- Merck & Co. (North Wales, PA)
- …-Primary activities include, but are not limited to: Monitors the quality , accuracy, and timeliness of biomedical literature screening, adverse event reporting, ... biomedical literature, including conference abstracts Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... Research Organizations) and manage oversight. The position will partner with internal and external stakeholders to optimize Statistical methods, processes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from all Daiichi Sankyo regions in scope.- Responsible for developing high quality solutions based on Functional Design documents. Perform system customization and ... and practices in performing required work.- Responsible for the development of internal staff and on-boarding of external vendors to accommodate emerging projects… more
- Eisai, Inc (Nutley, NJ)
- …initiatives related to the care pathway inclusive of diagnostics, infusion, and monitoring . This work will require strong collaboration with our CRC team and ... of the promotional elements and messaging targeting sites of care.Partner with internal business partners and agency partners in the execution of omnichannel content… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports ... data integrity, site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external… more
