- Merck & Co. (Upper Gwynedd, PA)
- …questions per established business processes and systems.-Identify, communicate and escalate potential regulatory issues to GRACS CMC management , as ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...associated CAPAs or process deviations, and coordinating the end-to-end management of these. They will also be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... resources.Plan, allocate, and utilize resources and prioritize assignments. Contribute to management and escalation of issues for resolution.Coordinate vendor… more
- Merck & Co. (Boston, MA)
- …systems such as databases, literature platforms, and pharmacopoeiasCollecting and reporting on resource usage statistics, and conducting assessments regarding ... clearly and concisely to diverse audiences, including researchers, clinicians, regulatory affairs professionals, and other stakeholdersCustomer Focus - Driven to… more
- Merck & Co. (Durham, NC)
- …lean lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit ... implement new analytical technologies that expand site capabilities.- Apply project management concepts and techniques as they relate to laboratory testing start-up,… 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)
- 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)
- …clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting , publication, and presentation at national and ... 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
- 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)
- 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
- Aequor (Thousand Oaks, CA)
- …to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies. Reporting on team and plant metrics to ensure ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outside the department. Engages with external stakeholders regarding government reporting requirements and operational assessments. Relationships Reports to the ... Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships… more
- Eisai, Inc (Raleigh, NC)
- …(MBRs)Assist with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation, and reporting of ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- AUROBINDO (Durham, NC)
- …new and existing programs, eg workplace harassment, performance management , management development training, etc.Assist with employee relations issues , as ... goal-setting processes.Support managers in delivering feedback and managing performance issues .Promote employee development and training initiatives.HR Reporting … more
- Aequor (Tampa, FL)
- … issues , problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible. Stop work where deemed necessary to ... and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers ... different phases.The VP of Global Clinical Operations is responsible for the management , oversight, and direction of the clinical operations function in the… more
- Lundbeck (Joliet, IL)
- …based on customer needs and organizational goals, incorporating "total office" account management . Local Market & Therapeutic Area Expertise - Gather and validate ... on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical… more
- AUROBINDO (Durham, NC)
- …portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality ... control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevelop and execute statistical analysis and reporting deliverables under the guidance of a senior-level programmer supporting early-phase oncology ... and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and document requirements… more
- Merck & Co. (Durham, NC)
- …ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist ... Issue Resolution (with appropriate escalation as required). Resolve Technical Issues (Investigations, CAPAs, Process Improvements, Source Changes, Technical Transfers,… more
