- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and ... Compliance and leads global quality support to all internal...Manufacturing groups and associated functional areas related to the Product Quality Complaint (PQC) system. They also support the… more
- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... provide recommendations to Regulatory CMC leadership team as appropriate.Provide regulatory leadership as needed in product in-license/due diligence review, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory , and business perspectives to ensure compliance with evolving ... organization inclusive of regional Labeling Strategy groups and Labeling Operations Compliance across the development product portfolio. Oversee the processes… more
- Eisai, Inc (Nutley, NJ)
- …assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and ... therapeutic area. Communicate and represent these plans to upper management/ senior leadership. Continuously update plans and inform stakeholders of progress.She/He… more
- Catalent (San Diego, CA)
- …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by management to check principles of assuring patient safety, data integrity and regulatory compliance are sufficient Monitor and escalate GxP compliance ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Director, Supply Chain Operations. This position regularly interacts with the senior leadership in Pricing & Contracting, Regulatory , Marketing, Legal, IT ... maximize your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand...execution of commercial supply chain activities to ensure seamless product flow to serve all our patients. You will… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations as ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project team.Experience in regulatory compliance expectations across all phases of product development to ... and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP)… more
- Eisai, Inc (Nutley, NJ)
- …of Oncology, Neurology, and Commercial Services/Value and Market Access. Aligning training with Compliance , Legal, Regulatory , Medical, Sales and Brand will be a ... organization by enhancing the capabilities of the Sales Team through initial product training, advanced product training, improved selling skills, disease state… more
- Merck & Co. (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance , operational excellence, pipeline program support, financial, ... Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to… more
- Eisai, Inc (Nutley, NJ)
- …a biopharmaceutical manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in leading ... multidisciplinary matrix team within EisaiAdvanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to operate a motor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure product reliability, quality, efficacy, and complianceOversee compliance auditing program to fulfill regulatory requirements.Follow applicable ... expert on GxP compliance . He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela on all… more
