**Role Description:** The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgen’s Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC). This role will shape, coordinate and provide input in the development of […]
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As part of Pfizer North America, this individual will report directly to the I&I Access & Reimbursement Regional Director. The Field Reimbursement Colleague will perform their duties under the strategic vision of the Pfizer Business Units’ overarching access and reimbursement plan and compliance standards. It will be this person’s role and responsibility to: + Conduct […]
**Group Purpose** Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regulatory strategy. The group also obtains and maintains local pharmaceutical company licenses and foreign manufacturing accreditation. **Job Summary** The […]
**ABOUT THE ROLE** The Strategy and Business Performance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by helping leaders understand, measure, and continuously improve performance. The Business Performance Manager is a member of the Transformation Execution team. This team is responsible for helping leaders […]
**Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on […]
**Position Purpose** • Provides pharmacometric expertise and leadership to projects. • Responsible for developing model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners. • Responsible and accountable for conducting and reporting quantitative analyses which integrate knowledge […]
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