11 lead regulatory scientist jobs found in Madison

Job Description Oracle Health Data Intelligence is hiring a Lead Regulatory Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within HDI's Regulatory & Medical Device organization. You will serve as a senior regulatory subject-matter expert who has lived both sides of the process - as a reviewer and as a submitter - bringing real-world regulatory judgment to HDI's global medical device strategy cross our product portfolio. This role is critical to shaping how Oracle delivers compliant, trusted, and scalable AI/ML-driven healthcare products across U.S. and European markets. At Oracle Health Data Intelligence, our mission is to transform healthcare through trusted, intelligent technology -helping providers, life sciences organizations, and health systems deliver safer care, faster innovation, and better patient outcomes at global scale. HDI is uniquely positioned at the intersection of:...

Job Description Oracle Health Data Intelligence is hiring a Lead Regulatory Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within HDI's Regulatory & Medical Device organization. You will serve as a senior regulatory subject-matter expert who has lived both sides of the process - as a reviewer and as a submitter - bringing real-world regulatory judgment to HDI's global medical device strategy cross our product portfolio. This role is critical to shaping how Oracle delivers compliant, trusted, and scalable AI/ML-driven healthcare products across U.S. and European markets. At Oracle Health Data Intelligence, our mission is to transform healthcare through trusted, intelligent technology -helping providers, life sciences organizations, and health systems deliver safer care, faster innovation, and better patient outcomes at global scale. HDI is uniquely positioned at the intersection of:...

Position Objective: Provide services as a Senior Advisor in support of the overall functions of the Office of the Director (OD) within the National Institutes of Health (NIH). Duties and Responsibilities: Provide recommendations and guidance to support NIH's goal to reduce/ replace the use of animals in biomedical research, drug development, and regulatory testing. Develop policies that bridge the transition to non-human research models. Create strategies to implement policies, anticipate scientific/ regulatory challenges, and bring the intra- and extra-mural communities into alignment with NIH's scientific goals involving novel alternative methods. Build community engagement to accelerate a transition toward human-relevant, non-animal methods. Work with the research community, regulatory scientists, and policymakers to identify barriers, develop solutions, and advance technologies that modernize science and improve public health outcomes...

Senior Scientist I, Quality Control (Data Review Team) Position Summary: Work Schedule: Monday - Friday, core hours 8am-4pm 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics. The Senior Scientist I in the Quality Control (QC) data review team will be responsible for testing products, raw materials and the manufacturing environment to ensure Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. Other duties will include data review/archiving, database entry/review and contributions to process...

Job Description Are you passionate about transforming healthcare and life sciences through data, AI, and intelligent platforms? Oracle Health Data Intelligence is building the next-generation Life Sciences Intelligence Suite - a unified, AI-powered platform that enables pharmaceutical and healthcare organizations to drive better outcomes through data-driven decisions, trial optimization, and real-world evidence. We're looking for an experienced product leader who thrives at the intersection of life sciences, AI, and cloud technology. This individual will guide the development of a modern, agentic SaaS platform that brings together today's fragmented applications - from clinical trial management to safety monitoring - and rationalizes them into a cohesive, high-value intelligence ecosystem. Are you passionate about transforming healthcare and life sciences through data, AI, and intelligent platforms? Oracle Health Data Intelligence is building the next-generation Life...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY delivers unparalleled service in business intelligence and digital analytics built on a blend of custom-developed methods related to customer analytics, data visualization, and optimization. Increasingly we also are working at the cutting-edge of machine learning and artificial intelligence, particularly in the space of generative AI, enabling our clients to leverage the newest technologies securely and at scale. We leverage best practices and a high degree of business acumen that has been compiled over years of experience to ensure the highest level of execution and satisfaction for our clients. At EY, our methods are not tied to any specific platforms but rather arrived at by analyzing business needs and making...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. The opportunity Our Artificial Intelligence and Data team helps apply cutting edge technology and techniques to bring solutions to our clients. As part of that, you'll sit side-by-side with clients and diverse teams from EY to create a well-rounded approach to advising and solving challenging problems, some of which have not been solved before. No two days will be the same, and with constant research and development, you'll find yourself building knowledge that can be applied across a wide range of projects now, and in the future. You'll need to have a passion for continuous learning, stay ahead of the trends, and influence new ways of working so you can position solutions in the most relevant and innovative way...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. The opportunity Our Artificial Intelligence and Data team helps apply cutting edge technology and techniques to bring solutions to our clients. As part of that, you'll sit side-by-side with clients and diverse teams from EY to create a well-rounded approach to advising and solving challenging problems, some of which have not been solved before. No two days will be the same, and with constant research and development, you'll find yourself building knowledge that can be applied across a wide range of projects now, and in the future. You'll need to have a passion for continuous learning, stay ahead of the trends, and influence new ways of working so you can position solutions in the most relevant and innovative way...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY delivers unparalleled service in business intelligence and digital analytics built on a blend of custom-developed methods related to customer analytics, data visualization, and optimization. Increasingly we also are working at the cutting-edge of machine learning and artificial intelligence, particularly in the space of generative AI, enabling our clients to leverage the newest technologies securely and at scale. We leverage best practices and a high degree of business acumen that has been compiled over years of experience to ensure the highest level of execution and satisfaction for our clients. At EY, our methods are not tied to any specific platforms but rather arrived at by analyzing business needs and making...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. The opportunity Our Artificial Intelligence and Data team helps apply cutting edge technology and techniques to bring solutions to our clients. As part of that, you'll sit side-by-side with clients and diverse teams from EY to create a well-rounded approach to advising and solving challenging problems, some of which have not been solved before. No two days will be the same, and with constant research and development, you'll find yourself building knowledge that can be applied across a wide range of projects now, and in the future. You'll need to have a passion for continuous learning, stay ahead of the trends, and influence new ways of working so you can position solutions in the most relevant and innovative way...

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. The opportunity Our Artificial Intelligence and Data team helps apply cutting edge technology and techniques to bring solutions to our clients. As part of that, you'll sit side-by-side with clients and diverse teams from EY to create a well-rounded approach to advising and solving challenging problems, some of which have not been solved before. No two days will be the same, and with constant research and development, you'll find yourself building knowledge that can be applied across a wide range of projects now, and in the future. You'll need to have a passion for continuous learning, stay ahead of the trends, and influence new ways of working so you can position solutions in the most relevant and innovative way...