- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... 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… more
- Sunrise Senior Living (Summit, NJ)
- …Participate in the development of the Individualized Service Plans (ISP). Transcribe orders. Risk Management and General Safety Partner with community team to ... national/provincial regulations pertaining to occupational health and safety requirements, promoting Risk Management programs and policies, and adhering to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategies and capabilitiesAdvanced data and analytics including oversight of deployed data scientistsPartner with GOMA functions and lead efforts to advance ... of mutual interestRepresent GOMA on internal digital governance committeesChange management /SMEContinuously monitor the external landscape to identify innovations and… more
- Merck & Co. (Rahway, NJ)
- …that advances communications capabilities, continuously reassessing priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery ... regulations and standards, partnering with compliance and quality teams as needed. Risk & Issue Management Capture and manage risks, impediments, assumptions,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the US and Canada...privacy solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires… more
- Merck & Co. (Rahway, NJ)
- … Lead /Support continuous improvement initiatives for design control and risk management processes Identify and eliminate process inefficiencies using ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on...data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software… more
- 4370918 (Edison, NJ)
- …and financial worthiness of loan/transaction parties. If relevant, performs ongoing credit risk management for assigned portfolio. May coach and/or review the ... expert for certain asset classes, and may represent or lead the department on special projects or assignments. Using...to ensure they adhere to and support PNC's Enterprise Risk Management Framework. Qualifications Successful candidates must… more
- Merck & Co. (Rahway, NJ)
- …and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Merck & Co. (Rahway, NJ)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... (CSO), Logistics and Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment as well as… more
- ValSource, Inc. (Rahway, NJ)
- …is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management : Interface with clients, lead teams of validation… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
