Amgen

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.

Drive report timelines and escalate risks or delays to team leads or management. Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template.

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director.

Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information

Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations

Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry