- Merck & Co. (Rahway, NJ)
- …stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology )Reporting into the Director Packaging Distribution, Components and Systems… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate ... science is applied to deliverables for new product introductions and technology transfers across the network.Drive proactive risk management activities,… more
- Formation Bio (New York, NY)
- …vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Formation Bio (New York, NY)
- …to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support ... 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)
- …Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk Management, Stakeholder Engagement, Technical ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Merck & Co. (Rahway, NJ)
- …Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance , Shift Work, TeamworkPreferred Skills:Current ... compliance .Schedule Adherence: Understands schedule adherence impact and communicates risk .- Maintains a continuous improvement mindset and implements initiates… more
- Formation Bio (New York, NY)
- …all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and ... 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)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology , to… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... development teams within and external to Device Development & Technology . The incumbent must be able to work well with all levels of employees and be able to… more
- Merck & Co. (Rahway, NJ)
- …Process to manage assurance of supply, quality, service, cost, innovation and regulatory compliance within Global or International category of spend, resulting ... implementation of procurement strategy, Global Category Management, contract management, risk management, stakeholder management, and supplier value management. They… more
- Merck & Co. (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Rahway, NJ)
- …scientific applications and lead squads to build user-friendly scientific data and technology products; handle risk assessment and vendor engagement as needed.- ... together product management, engineering, and data science expertise. We enable data, technology and services that accelerate our scientists' ability to discover and… more
- Merck & Co. (Rahway, NJ)
- …project managers, vendors, and communications stakeholders to refine, scope, and deliver technology solutions. Regulatory & Compliance Ensure technology ... Job DescriptionOur Company's Information Technology organization partners with colleagues across the business...communications comply with relevant regulations and standards, partnering with compliance and quality teams as needed. Risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …collaboration with cross-functional teams both within and outside of Device Development & Technology . The incumbent must be able to work well with employees at all ... development, such as manufacturing process development and validation, design control, risk management, material and molding, design validation to create and execute… more
- Merck & Co. (Rahway, NJ)
- …and targeting frameworksEnsures cross-functional consistency with tech, data, and risk /legal functions on experience and regulatory alignmentManagerial ... The role also owns the strategy and optimization of the marketing technology stack - including CRM, content, web, and consent tools-to enable personalized,… 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 ... standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics,… more
- Coinbase (New York, NY)
- …Audit is to objectively evaluate and audit the effectiveness of governance, compliance , risk management, and control process. The in-house Coinbase Internal ... who believes in the power of crypto and blockchain technology to update the financial system. We want someone...Audit team is responsible for strategic analysis, risk assessments, development of the audit plan, project management,… more
- Guidehouse (New York, NY)
- …roles-preferably within financial services or banking technology environments + Operational risk and/or big bank compliance (first or second line of defense) ... management frameworks, guidelines, and policies + Ensure alignment with regulatory requirements + Communicate risk and control...+ Banking regulations, compliance , and risk management requirements + … more
- Deloitte (New York, NY)
- … Technology , Computer Science, or a related field. + 5+ years in risk management, regulatory compliance , or consulting (industry or professional ... Maintain accurate records of compliance activities, audit findings, and regulatory communications. The TeamOur Enterprise Operations & Risk offering enables… more
