- Merck & Co. (Rahway, NJ)
- …Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory Affairs & ... and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… 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
- Merck & Co. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,… 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
- 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
- Eisai, Inc (Providence, RI)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... activities. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… 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
- Capital One Bank (Williamsburg, VA)
- Director , Payment Network Technology RiskCapital One is one of the fastest growing organizations in the world today, powered by our passion for our customers. We are ... innovation through technology, we equally prioritize cybersecurity, reliability, software quality , and data management. Technology & Data Risk Management (TDRM)… 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations… more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution ... 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
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good distribution ... execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a team… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo-lead the implementation of the next… more
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