Amgen Inc.

Global Patient Safety Product Manager - Thousand Oaks, CA. Provide strategic oversight for Global Patient Safety processes and technical document deliverables. Preparing submission-ready components from internal contributors according to regional regulatory guidance relying on regulatory- commitment database, Appian, Liquent, and Microsoft SharePoint; liaising between therapeutic area teams and business process owners to ensure alignment of global regulatory and safety plans within signal management, risk management, periodic reports, labeling, global regulatory affairs, and commercialization; creating and submitting regulatory dossiers according to fda requirements, and ectd guidance and specifications; developing and tracking multiple therapeutic product project timelines for cross-functional deliverables within global regulatory affairs and safety; and demonstrating knowledge of regulatory submission document standards, including regulatory compliant documents, interdependency between regulatory submission documents throughout product lifecycle. 

We are an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of race, color, national origin, religion, gender, age, veteran status, political affiliation, sexual orientation, marital status or disability (in compliance with the Americans with Disabilities Act) with respect to employment opportunities.