- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with leadership across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated ... grows. Relationships Reports to the Sr. Director, Patient Support Solution Quality / Safety Associate Director. Interacts with colleagues within Patient Support… more
- Merck & Co. (Durham, NC)
- Job DescriptionLead Technician, Maintenance (O4) Lead Maintenance Technician will be a leader with strong interpersonal, communication, and collaboration skills ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (South San Francisco, CA)
- …in cell-based model and assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) department. ... and implement best experimental practices to improve assay operation, quality , and overall productivity.Identify, evaluate, and champion new enabling technologies… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... practices and leverage lab automation to improve assay operation, quality , and overall productivityIdentify, evaluate, and champion new enabling technologies… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process ... projects with many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.Require minimal direction… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …team that includes but is not limited to quality assurance, quality control, operations, engineering, maintenance, calibration, safety , supplier quality , ... will be expected to gather data from various sources across the organization to lead and perform Root Cause Analysis to determine the most likely cause of the… more
- Merck & Co. (Durham, NC)
- …like ADP Ensure that training and certification are assigned and completed as expected - Quality & Safety Compliance: Foster strong safety culture on the ... order to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates and embraces an inclusive team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …& Beverage or Automotive production, leadership skills, and a commitment to excellence in quality and safety . The Plant Manager will be responsible for ensuring ... all safety regulations and standards, implementing best practices for workplace safety and employee training. Quality Assurance: Maintain high standards of … more
- Merck & Co. (Rahway, NJ)
- …Crystallization Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing ... is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with standard operating procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and ... Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You will be… more
- Merck & Co. (Rahway, NJ)
- …Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk ... & Development Division Scientists, Maintenance, Automation, Plant Operations, and Safety ), Engineering Firms, and Vendors to progress deliverables.The Associate… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the clinical ... the clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve… more
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