Senior Associate Regulatory Labeling - United States
The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.
Triage requests through the LEXA tool for timeline waivers and deviations from core or reference label content
Track and report on bundling of core documents to Labeling Strategists and RA
Track and report on upcoming CDS/Global labeling changes and monitors project deadlines
Provide US, and other regional labeling operational support, including formatting, templates, SPL, QC, translations support, including translation memory management
Support local regulatory by providing guidance in maintaining data in LEXA and documents EPIC, including clarification of processes
Support management of global labeling vendors to ensure established SLA’s are met (e.g. translations, Quality Control checks, etc.)
Bachelor’s degree and 2 years of Regulatory, Compliance or Quality experience
Associate’s degree and 6 years of Regulatory, Compliance or Quality experience
High school diploma / GED and 8 years of Regulatory, Compliance or Quality experience
Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
Works well independently and within teams
Use of document management tools
Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
Time and project management skills
Ability to take initiative and drive results
Tolerance for ambiguity
Proficiency in anticipating and resolving problems
Oral and written communication and presentation skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.