- Merck & Co. (Rahway, NJ)
- …Staff, Negotiation, Post Marketing Surveillance, Product Lifecycle Management (PLM), Product Upgrades, Regulatory Compliance , Scientific Leadership {+ 1 ... development to manufacturing, ensuring robust introduction, qualification, and performance monitoring. Regulatory Compliance :Collaborate closely with R&D and Manufacturing… more
- Merck & Co. (San Diego, CA)
- …Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , Regulatory Reviews, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …- Accelerated timelines for site, filing, and launch readiness- - Improved access to product and process data - Streamlined transfer of process and product ... supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all regulatory activities related to the review, approval, and compliance of advertising and promotional materials for the company's pharmaceutical products. ... culture of collaboration, innovation, and continuous improvement within the team. Compliance and Risk Management:Proactively identify potential regulatory risks… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... global regulatory strategy plans to facilitate efficient and driven product developmentMonitor the evolving regulatory competitive landscape to identify… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that all activities… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product Development The Mixed Modalities team within Sterile Product Development is responsible ... development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Merck & Co. (Rahway, NJ)
- …with internal and external stakeholders such as drug substance, drug product , device, analytical, regulatory , project leaders, manufacturing sites, and ... Job DescriptionReporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is… more
- Merck & Co. (Boston, MA)
- …and Development Sciences (RaDS) value team in R&D IT brings together product management, engineering, and data science expertise. We enable data, technology and ... change the course of human health. In the RaDS value team, the Product organization is responsible for implementing capabilities and associated services to advance… more
- Merck & Co. (Durham, NC)
- …Reviews, Operations Support, Process Optimization, Production Scheduling, Production Support, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting End ... Conforms to established safety procedures in accordance with OSHA and other regulatory agencies- Identifies and addresses compliance , environmental, safety, and… more
- Merck & Co. (Rahway, NJ)
- …Support iterative updates to data models as new sources are connected or regulatory requirements evolve.Data Product Support and Evolution: Develop and maintain ... data products that enable auto-generation of regulatory filing content. Collaborate with product owners...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …robust solutions and approaches are developed by working teams supporting the product .Compile with our company's Global and regulatory requirements and execute ... Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements,… more
- Merck & Co. (Durham, NC)
- …Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... innovative technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise. This… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... excellence and compliance and working toward building a quality mindset with...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product… more
- Merck & Co. (Durham, NC)
- …Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and… more
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