- Insmed Incorporated (NJ)
- …the integration of new technology and processes to enhance patient safety and benefit risk management . The ED will provide day-to-day leadership and guidance to ... the Medical Safety Strategy and Benefit- Risk Management group within DSPV to ensure...accurate, and compliant.Lead the analysis and interpretation of safety data for inclusion in regulatory submissions and marketing applications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work.- Proactively identifies and manages risks for the data management function and supports functional risk identification/ management efforts ... skills in continuous improvement, project management , change management , and risk management . Responsibilities...lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management … more
- Revel IT (Tucson, AZ)
- …for quality implementation in complex projects in the following areas: project risk management , critical path analysis, scenario creation and analysis, budget ... project/product teams as well as the broader organization in holistic planning, project risk management , scenario creation as well as critical path analysis,… more
- Eisai, Inc (Nutley, NJ)
- … Risk Management , Mentoring/ People Development, Stakeholder Management (Legal/ Compliance )Eisai Salary Transparency Language:The base salary range ... business leaders and collaborate on remediation strategies Support investigations by conducting data reviews to identify potential compliance risks or violations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Contract Management and Digital Enablement). The Director Patient Safety Data Acquisition will provide strategic and operational leadership to the Patient Safety ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities,… more
- Merck & Co. (Rahway, NJ)
- …Communications, Customer-Focused, Data Analysis, Driving Continuous Improvement, Financial Risk Management (FRM), Inventory Control Management , Key ... design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change … more
- 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)
- …operationsNew Products including supply chain design, operations and/or planning - Risk Management and Business/Financial acumenGreen Belt or Black BeltRequired ... New Product Introduction (NPI), New Product Introduction Process, Operation Risk Management , Pharmaceutical Management , Pharmaceutical Manufacturing,… more
- BioAgilytix (Durham, NC)
- …environment. The Cybersecurity Lead will unify existing policies into a streamlined, risk -based framework, ensure compliance with standards such as ISO 27001, ... roadmap, aligned to industry frameworks (NIST CSF, ISO 27001).Oversee governance, risk , and compliance activities, including policy development, regulatory… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Applied Engineering, Change Management , Combination Products, Compliance Packaging, Continual Improvement Process, Cross-Cultural Awareness, Data ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods… 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)
- …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)
- …Outsourcing Management , Procurement, Production Planning, Relationship Building, Risk Management , Stakeholder Negotiations, Strategic Procurement, Strategic ... & Manage Contracts:-Lead complex negotiations and manage agreements to reduce risk and maximize value.Supplier Relationship Management :-Build strong partnerships… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment, risk … more
- Merck & Co. (Rahway, NJ)
- …understanding of Design Controls (21 CFR 820.30) Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU ... Method Validation, Microscopies, Product Development, Project Leadership, Prototyping, Quality Management , Rheometry, Risk Management , Statistical Analysis,… more
- Merck & Co. (Rahway, NJ)
- …Planning, Project Management , Project Procurement Management , Regulatory Compliance , Risk Management , Strategic Procurement {+ 5 more}Preferred ... and category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… 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 ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… 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
- Insmed Incorporated (NJ)
- …to apply risk -based approaches, maintain validated state, and drive continuous compliance in support of patient safety and product quality. The position requires ... compliance with 21 CFR Part 11, Annex 11, data integrity, and electronic records/electronic signature requirements.Collaborate with IT System Owner,… more
