- 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 ... lifecycle management . This individual will oversee device risk management activities to ensure the delivery...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… 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 ... complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …rigorous feasibility, viability, and impact assessments to inform leadership decisions and de- risk scale-up. Novo Nordisk is currently in the process of adjusting ... Patient Support Solutions, Enterprise Insights, Market Access and Public Affairs (MAPA) Alternative Model team and other USO MPS teams and serves as a key member… more
- Merck & Co. (Rahway, NJ)
- …of GCP/ICH and worldwide Regulatory Health Authority requirements.Has delivered effective CAPA management solutions.Has worked with risk management tools and ... and Acquisitions (M&A), Operations Support, Pharmaceutical Management , Quality Management , Regulatory Inspections, Regulatory Submissions, Risk Assessments, … more
- Merck & Co. (Rahway, NJ)
- …managing the supply of direct and indirect materials, performing the supplier relationship management , supply risk assessment with actions in place and regular ... role includes leading the team to support overall category management for the packaging category led by the global...be expected to act as an exemplar and role model and deliver role model examples of… 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)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying ... strategies and drive continuous improvement in design control and risk management processes. This individual will be...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… 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)
- …easements and rights-of-way) Development and construction (design-build, EPC, CM-at- risk , construction management , architect/engineer, and ancillary agreements) ... real estate transactions and other agreements. Responsibilities: Work closely with management in Global Real Estate Services, Facilities, and regional business units… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategies In-depth knowledge of global… 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)
- …Daily check-in with the offshore team and delegate tasks Undertaking basic risk management activities. Maintain documentation of risks, threats, vulnerabilities, ... Multi- Management , Product Backlog Management , Project Management , Risk Management , Security ...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… more
- Merck & Co. (Rahway, NJ)
- …and cross-functional projects.Ensure all innovations meet regulatory compliance, risk management , and enterprise operational standards.QualificationsBachelor's ... enterprise frameworks, including Zero Trust, Protect the Enterprise, and Defend model initiatives.Innovation Leadership & EnablementAct as a trusted advisor to… more
- Merck & Co. (Rahway, NJ)
- …manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer ... systems such ICD-9, ICD-10, CPT, NDC, LOINC; data standards like Common Data Model (CDM); version control toolsFamiliarity with the fields of Outcomes Research and… more
- Merck & Co. (Rahway, NJ)
- …members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and ... industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment: Able to gown and work in Grade… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment, Innovative Thinking, Interpersonal Relationships, Mammalian Cell Culture, ... Molecular Biology, Omics Technologies, Process Characterization, Project Leadership, Project Management , Proteomics, Scientific Leadership {+ 3 more}Preferred Skills: Current… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Merck & Co. (Rahway, NJ)
- …activities to go live with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide ... Company (eg our Company's Manufacturing Division) to build or risk -mitigate infrastructure Position Qualifications: Education Minimum Requirement: Bachelor's degree… more
