- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to...acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards. This position… more
- Merck & Co. (Rahway, NJ)
- …Team to - lead the engineering efforts for the Security and Compliance Product which includes all ServiceNow applications related to security such as Integrated ... Risk Management, Security Operations and Business Continuity Management as...: - Gain deep subject-matter expertise within security and compliance processes, systems, and data. - Follow and apply… more
- Merck & Co. (North Wales, PA)
- …excellence practices such as technical standards, process platforms, operational procedures, and laboratory safety. Position Qualifications :Education Minimum ... in support of the following: process performance qualification (PPQ), risk assessment, control strategy, process comparability reports, and/or regulatory… more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Merck & Co. (Rahway, NJ)
- …Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of ... to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists.- The… 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 ... to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country ... on - boarding and off - boarding of employees, compliance to initial and ongoing trainings. Train and oversee...Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads ... strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources...Audit and Compliance QA function to develop compliance and risk criteria, in order to… more
- Merck & Co. (North Wales, PA)
- Job Description Job Summary: This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this ... skills in-support of our clinical trials. Job Responsibilities: Responsible for the operational planning, feasibility, and execution of a clinical trial.May serve as… more
- Merck & Co. (Rahway, NJ)
- …audit and data integrity reports to identify, investigate and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies ... and technology portfolio and information governance programs; and design and lead technology-related solutions to further the strategic goals of the department.… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impactProactively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to establish and maintain processes, procedures and controls to ensure compliance with all relevant internal and external requirements and regulations relating ... and other safety information in the US and Canada. Overall responsible for compliance with US drug and device safety reporting regulations, Health Canada regulations… more
- Tris Pharma (Monmouth Junction, NJ)
- …incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, ... Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and ... Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical expertise in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational Research, ... Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, agencies and healthcare associations to develop and implement congress operational programs, budgets and tactics for the successful and compliant execution ... that would best support the company and brand objectives.- Lead planning and execution weekly meetings with Global and/or...Work Breakdown Structure (WBS).- Responsible for anticipating and managing risk to ensure all parts of the project are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for best practices as per Legend Biotech policies and GXP requirements.Ensure compliance of operational activities with GXP, quality, training, EHS, security ... Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well as continuous improvement of cGMP Warehouse Operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …related quality events, CAPAs, and Out of Tolerance (OOT) situationsConducts basic risk mitigation options and advanced troubleshooting to identify root cause and ... maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standardsResponsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... units as well as external suppliers and partners Essential Functions Lead evaluation, design, and analysis of enterprise-wide solutions Translate business and… more
