- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... and immune disorders. We are currently seeking an IT Risk & Security Governance Intern for a year (June...required. Excellent written and verbal communication skills and time management skills are essential. Daiichi Sankyo, Inc. is an… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology )Reporting into the Director Packaging Distribution, Components and Systems… 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
- 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 ... provide overall leadership and strategic direction for the clinical project management functions in a technology -driven, AI-focused biotech environment. This… 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 ... paralegal teamExperience in legal operations, including strategic planning, project management , financial management , and technology implementationAdvanced… more
- Merck & Co. (Ames, IA)
- …and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform comprehensive and ... Quality Agreements.Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance.Implement standard Supplier Qualification process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... NJ.Role OverviewThe MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be… 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 ... teams both within and outside of Device Development & Technology . The incumbent must be able to work well...design verification, including but not limited to, design controls, risk management , materials & molding, process development… 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 ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Malware Analysis, Management Process, Penetration Testing, People Leadership, Risk Management , Security Information and Event Management ... correlation rules, and detection models tailored to the organization's unique risk profile and threat landscape. Continuously enhance and optimize detection… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... technology transfer programs in both development and lifecycle management , ensuring compliancewith relevant regulatory standards.Ensure robust technical plans, … more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... Lead efforts to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request for Quotation) Process… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutical Industry, Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation ... Management , Equipment Qualification, Facility Management , Good Manufacturing Practices (GMP), Information Technology (IT) Infrastructure, Maintenance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Process Review, draft, and negotiate a wide range of high-complexity, high- risk buy-side/supplier contracts, including master service agreements, technology /SaaS ... Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the...as required Perform other duties as assigned by senior management Provide Corporate Law Legal Support Provide legal support… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, biotech, or regulated life sciences.5+ years of experience in technology enablement for regulatory or safety, with management ... regulatory authoring/publishing platforms.Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing, PV case management /reporting, labeling/registrations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
