- Merck & Co. (Rahway, NJ)
- …business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide ... with a strong understanding of quality management systems and regulatory compliance .Exceptional project management skills and principled verbal… more
- Merck & Co. (Upper Gwynedd, PA)
- …with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global ... Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process… more
- Merck & Co. (Durham, NC)
- … Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities to ... issues effectively in a timely manner for proper resolution to ensure product quality PROJECT MANAGEMENT: Accountable for quality and/or technical… more
- Merck & Co. (Rahway, NJ)
- … Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, Strategic ... within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas… more
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, ... fitness. The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders. Primary Activities: PreNDA and… more
- Merck & Co. (Rahway, NJ)
- …particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent ... Curiosity, Pharmaceutical Development, Product Development, Product Lifecycle Management (PLM), Project Management, Regulatory Interactions, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …development.Knowledgeable of the Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- …Meteorology, Mitigated Risks, Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (Rahway, NJ)
- …large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Aequor (Thousand Oaks, CA)
- …senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting… more
- Merck & Co. (Durham, NC)
- …Excellence, Process Optimization, Process Troubleshooting, Production Operations, Production Support, Project Management, Regulatory Compliance , Teamwork, ... opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This… more
- Merck & Co. (Rahway, NJ)
- …digital wallets.Proven track record in vendor management, strategic planning, and regulatory compliance .Strong analytical, negotiation, and project ... a critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
