- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data ... Data Management deliverables meet/exceed project/study team expectations regarding quality , time, and cost and that Data Management documentation… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Merck & Co. (Rahway, NJ)
- …these commitments within specified-timelines with minimal oversight from the line manager .-Ability to proactively develop risk management and mitigation plans ... with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data ...team as an extended part of committee. Advise Study Data Manager on complex vendor management issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. 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
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our...Company 's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs,… more
- Eisai, Inc (Nutley, NJ)
- … data privacy standards. Your responsibilities span security operations, risk assessment, investigations, and compliance issue resolution for the Americas ... US's compliance with GDPR, HIPAA, CSL, and other relevant Security and Data Privacy standards through continual risk and security assessment.Collaborates with… more
- Merck & Co. (Austin, TX)
- Job DescriptionWe are currently searching for an experienced Network Infrastructure Delivery Manager to assume the role of Network Hyper-Deployment Squad Lead within ... delivery of Network Infrastructure projects, ensuring they meet deadlines and quality standards. This involves coordinating tasks, allocating resources, and removing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing ... support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the … more
- Novo Nordisk Inc. (South Houston, TX)
- … risk " diabetes patient population (Eg, providers, care coordinators, quality , population health, clinical pharmacy) Educate providers on strategies to improve ... Diabetes Education Program strategy. Interacting with health system KOLs, providers, quality , care coordinators, advanced practice providers, and the like to… more
- Novo Nordisk Inc. (Miami, FL)
- …of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and… more
- Merck & Co. (North Wales, PA)
- …the extended global team via primary market research projects, secondary data analysis and ad-hoc requests by proactively identifying strategic insights, answering ... questions, identification of information needs, identifying considerations from other data sources, development of research/analysis plans and management of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... n/a Essential Functions Business Partnering: Act as Business Support Project Manager for strategic projects & implementation Drive improvement initiatives at both… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... and on-site monitoring & oversight activities using various tools to ensure:o Data generated at site are complete, accurate and unbiasedo Subjects' right, safety… more
- Merck & Co. (Rahway, NJ)
- …pipeline progression and cross-functional execution by integrating planning capabilities, data science / engineering, and insight generation into our Research ... include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership to ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain IT Operations… more
- Bank of America (Charlotte, NC)
- EAC Compliance and Operational Risk Manager - Enterprise Data Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common ... EDR EAC Manager is responsible for engaging stakeholders from Enterprise Data , Strategy, Governance and Operations (EDSGO), Global Risk Management, Global… more
