- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts ... and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient… more
- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding… more
- Formation Bio (New York, NY)
- …tools to streamline workflows and accelerate decision-making. Drive cross-functional planning, risk management , and clear action tracking. Flex Capacity ... more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with our Business… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Insmed Incorporated (NJ)
- …the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety ... surveillance, risk management , and risk communication for assigned development products; perform medical assessment of individual adverse event reports… more
- Merck & Co. (Rahway, NJ)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying ... development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to apply his/her… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other… more
- Repligen (Waltham, MA)
- …years of hands-on experience in IT Audit, ITGC, or IT Risk Management within a public or large-scale company.Deep understanding ... digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Eisai, Inc (NJ)
- …and mitigate risks.Process Management Supports functional strategy execution and risk management initiativesDepartmental Subject Matter Expert (SME) and may ... teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... on paper basis audit and to monitor vendor performance management program. Support the issue and communication of audit... risk management activities completion for vendors and to periodically review… more
- Merck & Co. (Rahway, NJ)
- …with application of Lean Six Sigma principles, as well as Risk Management tools.Understanding of new product introduction, commercial supply, ... Packaging Engineering, Process Optimization, Product Packaging Design, Project Leadership, Risk Management , Root Cause Analysis (RCA), Technical Leadership,… more
- Aptyx (Charlotte, NC)
- …supplier engagement, raw material qualification, and specification development. Participate in risk management activities including design failure mode analysis ... qualification and raw material specification development. Familiarity with device level risk management activities. Experience leading technical workstreams or… more
- Merck & Co. (Boston, MA)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more
- Insmed Incorporated (NJ)
- …you have:Knowledge in negotiation of clinical trial agreements, regulatory matters, risk management and contract management .Experience in contract, ... a broad range of issues related to clinical development, clinical operations and risk management .Extensive ability to stay abreast of new laws, regulations and… more
- Merck & Co. (Rahway, NJ)
- …Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk Management {+ 4 more}Preferred Skills: Current ... as system development lifecycle (SDLC), assessments of data integrity, privacy, risk , and other aspects necessary for GxP useImplement automation solutions,… more
- Eisai, Inc (Nutley, NJ)
- …issues and mitigate risks.Process Management Drives functional strategy and risk management initiatives.Develops competency models and designs training and ... Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role is accountable for… more
- Merck & Co. (Rahway, NJ)
- …and Project Support, Program Management , Project Management , Project Management Office (PMO) Strategy, Risk Management , SAP Data Migration, ... USJob Description:The PMO Strategic-Planning will support the execution of change management , communication, and training strategies, plans, and activities to ensure… more
- Merck & Co. (Rahway, NJ)
- …Data Analytics, Driving Continuous Improvement, Global Sourcing Strategies, Results-Oriented, Risk Management , Strategic Sourcing, Strategic Thinking, Supply ... execution of sourcing strategies and initiatives, and the relationship and performance management of strategic suppliers of MRO Services globally. You will work… more
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