- 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
- 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)
- …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
- Wyndham Hotels & Resorts (Parsippany, NJ)
- …commerce and marketing technologies. + Contribute to project delivery oversight and risk management . + Exhibit excellent communication and referent leadership ... desired skills include empathy, vision, communication, decision-making, and stakeholder management ; strategic skills include product strategy and architecture roadmap,… 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
- Merck & Co. (Rahway, NJ)
- …and cross-functional projects.Ensure all innovations meet regulatory compliance, risk management , and enterprise operational standards.QualificationsBachelor's ... effort, accelerate response times, and improve enterprise resilience.Stakeholder & Program AlignmentPartner with senior leadership to prioritize innovation initiatives… more
- Merck & Co. (Rahway, NJ)
- …the network. Incorporate relevant digital tools to automate and improve project/ program management efficiency where relevant.Cross-Functional Team Leadership: in ... Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting,… 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
- Skanska (Parsippany, NJ)
- …key stakeholders across departments - including Operations, Accounting, Business Development, Risk , Strategy, and Marketing - to define, implement, and optimize a ... platform transformations + 7+ years of experience with change management and user adoption strategies, with a focus on...and financial well-being - **Competitive base salary, excellent bonus program , 401k, & Employee ownership program ** .… 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
- 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
- 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)
- …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
- 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
- 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
- Formation Bio (New York, NY)
- …development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives. ... with assessment of potential new assets from a technical and financial risk standpoint. About YouRequired Qualifications MS or PhD in pharmaceutical sciences,… more
