- 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
- 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
- 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)
- …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
- 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
- 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)
- …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
- 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
- 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
- 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
- Repligen (Waltham, MA)
- …and supplier information. Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high- risk suppliers, and common failure ... growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to… more
- Merck & Co. (Upper Gwynedd, PA)
- …not limited to, forecasting, reporting, and analyzing operating results; operational risk management and process improvement consulting; managing capital ... Economic Research, Finance Strategy, Financial Analysis, Financial Forecasting, Financial Management , Financial Modeling, Financial Risk Management … more
- Merck & Co. (Rahway, NJ)
- …participants with hands-on exposure to finance, accounting, auditing, analytics, risk management , and special projects.Throughout the program, individuals ... IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Audits Compliance , Audits Compliance , Budgeting, Business Administration, Business Management , Business… more
