- 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 ... commercialization, and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high-quality products… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with ... diligence efforts, support asset onboarding post-acquisition, and help build scalable program management infrastructure that enhances execution, visibility, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible to complete on paper basis audit and to monitor vendor performance management program . Support the issue and communication of audit plans, agenda ... program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the … 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 ... and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Organizational Change Management , Portfolio, Programme, and Project Support, Program Management , Project Management , Project Management ... 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)
- …Governance Management , Leadership, Oncology, Operational Excellence, Privacy Compliance, Quality Management , Risk Management and Mitigation, Risk ... for vendor selection, contracting input, performance oversight and portfolio management .Implements "Privacy and Compliance by design" frameworks from Enterprise… more
- Merck & Co. (Rahway, NJ)
- … - The complexity of categories and projects require high quality project and program management skills and a proven ability to manage change both internal ... managing the supply of direct and indirect materials, performing the supplier relationship management , supply risk assessment with actions in place and regular… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …problems, providing guidance to leadership including trade-off and implications assessment (value, risk , cost, time) to the project or program .Prepares and ... program plans. Having experience with global teams, budgetary management , resource planning, and fiscal awareness is preferred.Provide technical expertise of… more
- Bayer (Whippany, NJ)
- …licenses (eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license renewals) for the compound(s);Lead the matrix- ... management of clinical trial teams, collaborating across the organization...to interpret, discuss, and present clinical trial or section program -level data;Proven experience with FDA regulatory requirements and ICH… more
- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training ... process development.- Experience in supporting compliance investigations and change management .-- Ability to prepare or leverage Standard Operating Procedures (SOP)… more
- Merck & Co. (Rahway, NJ)
- …company, its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , ... Master in Business Administration or PhD preferred 4+ years of strategy management consulting experience from a top-tier firm (eg, BCG, McKinsey, Bain) Minimum… more
- Merck & Co. (Rahway, NJ)
- …manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer ... assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …projects.Support the enhancement and Global harmonization of the supplier qualification program , including management of the electronic systems for this ... Management Review (QMR).Support management of the Quality Management Review (QMR) program .Support continuous improvement efforts through the monitoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and budget related activities.Process-oriented with strong analytical skills for risk identification and management .Ability to translating complex analytics ... contributor in the reporting, forecasting, and budgeting cycles for the CARVYKTI manufacturing program (US & EU). This role will be responsible for partnering with… more
- Formation Bio (New York, NY)
- …you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk... Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manager, Employee Relations, is pivotal in ensuring consistent and thorough management of Employee Relations processes (including corrective action) across the ... business areas of support. They are responsible for consulting with management on best practices for coaching, performance and behavioral concerns while ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner ... partners to track changes to our material/ raw material program and develop best practices for evaluation of changes...same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME ... license agreements, and amendments. The role will be utilizing Procurement's Contract Lifecycle Management (CLM) platform on a daily basis and will be at the… more
