- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk management ... Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Risk Assessment Specialist as part of the Technical Operations team based in ... Role Overview This position will be responsible for leading and facilitating Risk Assessment Projects to the cGMP Clinical and Commercial Cell Therapy Manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …and data privacy standards. Your responsibilities span security operations, risk assessment, investigations, and compliance issue resolution for the Americas ... CSL, and other relevant Security and Data Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders… more
- Insmed Incorporated (Bridgewater, NJ)
- …This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and ... documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes.Challenge… more
- Merck & Co. (Rahway, NJ)
- …to implement `quality by design` within clinical development programs, using a risk -based approach. They will be responsible for the overall strategy for maintaining ... implementation of `quality by design` principles in assigned clinical trials.-Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with… more
- Eisai, Inc (Nutley, NJ)
- …role will be required to provide input into vulnerability management, risk management, security architect, security operations center operations, red/blue team ... security controls and processes to protect the organization's infrastructure assets.7. Risk assessment and mitigation: Collaborate with the Global Security &… more
- Merck & Co. (South San Francisco, CA)
- …but not limited to, performing laboratory safety inspections, equipment risk assessments, ergonomic evaluations, permit recording and review, conducting hazard ... testing and training.Supports the site's biosafety program by reviewing risk assessments and recommending engineering controls to reduce/eliminate exposuresDevelops… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and ... design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management, development plan/timeline management, scope management, stakeholder management, risk /issue management, finance and resource management, and conflict ... against the budget.Maintains global integrated project plans, project timelines, risk management, plans and communication plans. Supports scenario planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise for novel safety issues requiring safety surveillance and/or risk mitigation.Responsibilities- Research and Nonclinical Development: For select drug ... on the MOA and initial toxicological profile. Provide a first, preliminary benefit/ risk assessment and make available to senior leadership at DP0. Surface expert… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and consumables for compatibility with the Manufacturing process. Draft Process Risk Assessments for implementation of process changes. Requirements BS/BA required ... implementation. Support writing of MBRs and SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes. Ability to work independently… more
- Tris Pharma (Monmouth Junction, NJ)
- …safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in ... including, but not limited to: safety data review, signal detection, risk communication including safety information updates, potential risks mitigation, etc.… more
- Novo Nordisk Inc. (New York, NY)
- …Essential Functions Work with health systems accounts to identify "at risk " patient populations and utilize diabetes education following the ADA Standards ... makers responsible for the direct management and care for the "at risk " diabetes patient population (Eg, providers, care coordinators, quality, population health,… more
- Merck & Co. (North Wales, PA)
- …of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design ... Design Controls / CAPA / Purchasing Controls as it related to 21CFR820. Risk Management experience (ISO 1497124971, ICH Q9).Effective communication skills and working… more
- Merck & Co. (North Wales, PA)
- …our ability to anticipate changes in the market, prepare accordingly, and mitigate risk so we can continue ensuring appropriate patient access to our Company's ... to any state PDAB's affordability review of our Company's Oncology products.Model any risk to the business stemming from a state's affordability review and potential… more
- Merck & Co. (Rahway, NJ)
- …-The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and… more
- Merck & Co. (North Wales, PA)
- …biomarker and translational research strategy to test the hypothesis.--Alignment, risk mitigation & strategy implementation:- align with asset development team ... biomarker and translational research strategy to test the hypothesis.- -Alignment, risk mitigation & strategy implementation:- align the development team strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities to ensure compliance with contract expectations Understands & Applies Risk Management Practices: Ensures system design adheres to compliance requirements, ... and other technology standards both local and corporate Integrates current risk management procedures into processes, projects and systems Leverages knowledge of… more
- Novo Nordisk Inc. (Miami, FL)
- …trials, in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, ... leveraging Risk Based Quality Management (RBQM) principles and tools; executes...to balance multiple competing priorities, stakeholders, timelines and mitigate risk Bilingual fluency in Spanish and English is required… more
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