Regulatory Affairs Sr Mgr - Regional Regulatory Lead Asia Pacific and China (APAC) California-Ventura County
10/1/2014 7:24 AM

This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and executing regional regulatory strategies. To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market c  ...View Job
Regional Regulatory Group Leader -- Director Regulatory Affairs - Japan, Asia Pacific, Australia, and China (JAPAC) California-Ventura County
10/1/2014 7:24 AM

This role is the lead of a regional Regulatory Affairs organization within an assigned area. The purpose of this role is: * To provide management and leadership by advising on the development and execution of regulatory strategy and plans for regulatory agency interactions * To ensure appropriate regulatory input is provided into regulatory plans * To p  ...View Job
Global Safety Sr Mgr - Global Safety Risk Management Scientist California-Ventura County
9/30/2014 8:17 AM

This position can be based in either of our Thousand Oaks, CA or Cambridge, MA locations. Conducts Amgen safety risk management processes and activities. Ensures that safety risk management (RM) processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Establishes and maintains Amgen corporate safety risk management processes, r  ...View Job
Specialist HR Systems & Solutions - (Sr Business Analyst) California-Ventura County
9/26/2014 7:26 AM

Amgen is seeking a Specialist HR Systems and Solutions - (Sr Business Analyst) to join the Global HR Systems and Solutions team. This individual will help research, evaluate, plan, design and deploy technology-related HR initiatives in close collaboration with cross-functional business units (HR Operations, HR COE, HR Business Partners and Information Systems (IS)) and vendors. Main focus are  ...View Job
Regulatory Affairs Sr Mgr - CMC Sr Manager - Regional Lead California-Ventura County
9/25/2014 7:38 AM

To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The RA CMC Regional Lead is responsible for generation of the region specific regulatory strategy and providing feedback to the team for plans and exe  ...View Job
Human Resources Manager (HRBP) Massachusetts-Cambridge
9/25/2014 7:38 AM

The successful candidate will be the Human Resources Business Partner (HRBP) for Amgen’s Research and Development and Manufacturing Facility in Cambridge,MA . The HRBP will be a strategic partner for client group management teams to help their staff and organizations reach their full potential. This position provides the opportunity to develop solutions to a variety of complex H  ...View Job
Senior Counsel - Med Chem California-Ventura County
9/24/2014 7:28 AM

The candidate will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support. The candidate will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing and implementing legal strategie  ...View Job
Regulatory Affairs Manager -- Mobile Apps and Stand-Alone Software California-Ventura County
9/23/2014 7:46 AM

Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Gr  ...View Job
Statistical Programming Senior Manager California-Ventura County
9/23/2014 7:46 AM

The Statistical Programming Senior Manager will work in Amgen's Biosimilar organization supporting multiple products. * Represent the product programming function and participate in multidisciplinary project team meetings; * Collaborate closely with Biosimilar Statisticians and other functional team members; * Coordinate and oversee the development of dataset sp  ...View Job
Regulatory Affairs Manager -- Device and Combination Product California-San Francisco
9/23/2014 7:46 AM

The Regulatory Affairs Manager will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Support development and implementation of regulatory strategies and processes for both new and existing combination products (CPs) and innovative delivery devices. Registrations and Filings: <  ...View Job