LPM - Labeling Senior Associate

Career Category

Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

The Amgen Capability Center in Lisbon, Portugal (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities.  

The ACCP will be temporarily located at the Maleo – Saldanha, Av. da República 18, 1050-191 Lisbon. We’re already gearing up to have our brand-new permanent office ready in the vibrant city center of Lisbon by the spring of 2022.

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Labeling Process Management, Sr Associate

LIVE

What you will do

As part of Global Labeling (GL), and under the supervision of the Global Labeling Process Management Director, the Global Labeling Process Management, Sr Associate supports the Global Labeling Process Management team to manage labeling Process Management activites. The Global Labeling Process Management, Sr Associate also supports oversight of document management for regional documents, core labels and other related documents and Labeling vendor management.

Principal responsibilities include, but are not restricted to:

• Triage requests through the Labeling tool for timeline waivers and deviations from core or reference label content. 

• Track and report on bundling of core documents to Labeling Strategists and Regulatory Affairs.

• Track and report on upcoming CDS/Global labeling changes and monitors project deadlines.

• Provide European Union and other regional labeling operational support, including formatting, templates, QRD, Quality Control, readability, linguistic review, translations, including translation memory management.

• Support document management of all core documents, core illustrations and related documents

• Support local regulatory by providing guidance in maintaining data in Labeling tool and documents, including clarification of processes.

• Support management of global labeling vendors to ensure established SLA’s are met (e.g. translations, Quality Control checks, etc.)

WIN

What we expect of you

• Previous experience working in industry in support of European Labeling in creating EU Labeling documents and logistic support

• 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

• Relationship management

Minimum Bachelor’s degree and 2 years of related Labeling experience

• Degree in pharmaceuticals, natural science or medicine

• Previous experience working in industry in support of global labeling

• Project Management

• Fluent in English (oral and written)

THRIVE

What you can expect of us

• Vast opportunities to learn, develop, and move up and across our global organisation.
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits.
• Flexible work arrangements.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

.