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Senior Associate Regulatory Labeling - United States  

Amgen (company)

Posted on : 01 May 2017

Project Description

As part of Global Labeling (GL), reporting to the Labeling Performance, Sr Manager, the Labeling Performance, Sr Associate is responsible for supporting the monitoring and reporting on the health of the end to end labeling process through Quality System Managements, supporting continuous improvement projects, triaging BPM tool issues and enhancements to BPM owner and certification content development for Global Labeling roles.

The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and to drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.

Principal Responsibilities:
Reporting and tracking deviations and waivers timeline adherence
Create performance and metrics reports for Labeling KPI’s
Analyze issues
Support Quality System Management process: Support CAPAs for Global Labeling organization and vendors
Support the maintenance of global labeling SOPs and manual
Support Global Labeling Training Assignment and Onboarding
Triage BPM tool issues and enhancements to BPM owner
Maintain global labeling process consistency across tools, technology, training delivery, procedures, and timelines to enable effective and compliant labeling execution
Certification content development for Global Labeling roles

Basic Qualifications

Master’s degree
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

Preferred Qualifications

Knowledge of pharmaceutical or medical device regulations
Accomplish business results through 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
Tolerance for ambiguity
Proficiency in anticipating and resolving problems
Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint
Oral and Written Communication and Presentation Skills
Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
Ability to analyze data and report findings
Demonstrates leadership attributes
Project Management
Fluent in English (oral and written)

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.