- 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
- 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)
- …documents. Ensure all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, ... communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory , etc. at all levels. Establish, educate,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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)
- …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. (Rahway, NJ)
- …People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory ... NJ Site.Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory requirements.Lead… 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
- 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
- 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. (North Wales, PA)
- …management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting… 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
- 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
- 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)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Rahway, NJ)
- …Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance , Regulatory Compliance {+ 3 ... establish boundaries and ground rules for engagement with the EPs, while ensuring compliance / quality readiness of these suppliers at all times through the… more
- Eisai, Inc (Nutley, NJ)
- …company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads ... the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
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