- Merck & Co. (Rahway, NJ)
- …one or more of the QMS processes managed under GRACS( Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains an engaged ... a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge.-Applies capabilities to enhance quality and builds capabilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... potential. Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country/region in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships… more
- Merck & Co. (Rahway, NJ)
- … Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the Company's Research & ... Life Cycle deliverables and testing.Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... Thursday). Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and ... optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
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