The MDR Lead partners closely with cross functional teams to deliver high-quality, decision-ready clinical data in support of Amgen’s development strategy.
AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs.
GCP Subject Matter Expert, Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology. Experience in Quality Management, Quality Assurance. pharmaceuticals
Senior Manager QC Microbiology is responsible for leading and managing the Micro and Environmental Monitoring teams. This role involves setting goals, managing performance, and providing clear direction in line with company goals, with safety as the foundation of all activities.
This candidate will primarily work a shift-based schedule to enable the business in delivering Amgens mission to serve patients. The candidate may need to work outside of his/her routine workday to support business needs.
Develop and present key Competitive Intelligence deliverables for multiple internal business partners, primarily R&D, Commercial, and Legal stakeholders
Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization.