- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management ... device risk management activities, ensuring adherence to industry standards. Lead risk management workshops and training programs, facilitating… more
- Merck & Co. (Rahway, NJ)
- …to co-create assets, and internal initiatives to capture additional US first party data where needed. Lead data innovation initiatives to enable better ... downstream use cases in brand, forecasting, and patient supportHands-on experience with Enterprise data strategy, data management , developing data … more
- Merck & Co. (Rahway, NJ)
- …maintaining a profound knowledge of Good Clinical Practice with respect to digital data management (ie use of novel technology within clinical trials).The CQOM ... of GCP/ICH and worldwide Regulatory Health Authority requirements.Has delivered effective CAPA management solutions.Has worked with risk management tools and… more
- Merck & Co. (Rahway, NJ)
- …examples of good practice which can be shared and adopted throughout our Company. Sourcing Management - Adopt, lead , and implement Sourcing Management as a ... 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)
- …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)
- … 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)
- …Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk Management {+ 4 more}Preferred Skills: Current ... of new technology deployment such as system development lifecycle (SDLC), assessments of data integrity, privacy, risk , and other aspects necessary for GxP… 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)
- …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)
- …in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop teams, ... Process Improvements, Clinical Supply Chain Management , Contract Management , Customer Alignment, Customer-Focused, Data Compilation, Detail-Oriented,… more
- Merck & Co. (Rahway, NJ)
- … Analytics, Driving Continuous Improvement, Global Sourcing Strategies, Results-Oriented, Risk Management , Strategic Sourcing, Strategic Thinking, Supply Chain ... and Ireland where our company has its largest manufacturing footprint. Lead cross functional teams through the Sourcing Management...footprint. Lead cross functional teams through the Sourcing Management Process at global level as well as at… 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
- 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)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... Position Description: The Director of Commercial Strategy Development will lead and support strategy development for enterprise-critical commercial initiatives,… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data -science, machine learning, artificial intelligencePRDRequired Skills: Biological Manufacturing, Biological… more
- 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
- Bayer (Whippany, NJ)
- …difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports ... of this role, Senior Director, Digital Governance & LMR Lead , are to: Oversight of External Communication Procedure: Acts...of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration… 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- ... make a real difference, there’s only one choice. Sr Director, Global Clinical Lead , Diagnostic Molecular Imaging The Senior Director, Global Clinical Lead … more
