- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous improvement around… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data ...of current and future information needs Strong commitment to compliance and ethical standards in data handling… more
- Merck & Co. (Rahway, NJ)
- … Information Systems (PMIS), Project Planning, Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement {+ 5 ... Skills: Adaptability, Adaptability, Business Processes, Business Process Improvements, Change Management , Clinical Research, Cross-Functional Team Leadership, Data … more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... checks are performed and discrepancies resolvedOversee IP docketing system to ensure data integrity, accuracy, and compliance with rules and departmental… 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
- Merck & Co. (Rahway, NJ)
- …Analysis, Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , ... quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware,… 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)
- …development and implementation of procurement strategy, Global Category Management , contract management , risk management , stakeholder management , and ... of spend, resulting in breakthrough strategies which optimize value and ensure appropriate risk management . Understands the Sourcing Management Process and… more
- Merck & Co. (Rahway, NJ)
- …compliance .Schedule Adherence: Understands schedule adherence impact and communicates risk .- Maintains a continuous improvement mindset and implements initiates ... partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the...to increase efficiency or reduce risk to schedule adherence. Compliance :… more
- Merck & Co. (Rahway, NJ)
- …systems and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing ... Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director,...Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for… more
- Merck & Co. (Rahway, NJ)
- …and standards, partnering with compliance and quality teams as needed. Risk & Issue Management Capture and manage risks, impediments, assumptions, and ... Collaboration Tools, Communication, Communications Planning, Corporate Communications Strategy, Database Management , Data Integration, Detail-Oriented, IT Infrastructure … more
- ValSource, Inc. (Rahway, NJ)
- …21 CFR Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality, ... projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountability- Ethical, resilient, and committed to excellence- Skilled in risk management , team facilitation, and strategic planning- Experience in ... Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management , Regulatory Submissions, Risk Management ,… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …with privacy, consent, and targeting frameworksEnsures cross-functional consistency with tech, data , and risk /legal functions on experience and regulatory ... channels. This role oversees campaign orchestration, CRM/Veeva systems, omnichannel data standards, and digital/web capabilities to ensure a cohesive customer… 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)
- …and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable ... Cross-Functional Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Leadership, Life Science, Management Process,… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… 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
