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Global Pharmacoepial Affairs Specialist

Employer
Amgen
Location
Cambridge, MA
Start date
Nov 16, 2021

View more

Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Quality System

Live

What you will do

Lets do this. Lets change the world. In this vital role you will work on project management for Amgen globally relating to the Pharmacopeia Affairs Desk and related external engagement activities.

Key Responsibilities

  • Project Managing Pharmacopeia affairs globally for Amgen.
  • Gaining knowledge internally and externally about early signals, current hot topics and evolving issues impacting Amgen Operations globally and in region/countries
  • Setting up, manage and improve related data bases in External Affairs
  • Carrying out assessments, analysis of data sources and communication back into the organization through established channels.
  • Working internally to seek alignment, support and scientific knowledge on related developments in external landscape.
  • Representing Amgens approved positions in appropriate external organizations (e.g., PhRMA and/or EFPIA and/or BIO and/or PDA) by shaping the external environment including related policy initiatives.
  • Collaborating closely with regulators facilitated by industry associations, as assigned.
  • Taking on additional projects with focus on accountabilities or development opportunities, as applicable.
  • Providing support and act as backup to one another position in External Affairs
  • Traveling in country and internationally as required to fulfill the company needs (approx. up to 15%).

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a Specialist with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of Quality experience

Or

Bachelors degree and 5 years of Quality experience

Or

Associates degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

  • Experience in a laboratory e.g., Quality Control, Development, highly appreciated.
  • Understanding of global Regulatory and Quality requirements focused on GMP/GDP, QMS, Supply chain and potentially also CMC
  • Ability to interpret, synthesize, and communicate information, not simply summarize
  • Creative and independent problem solver
  • Ability to build relationships and use influence effectively in a variety of settings, both within the company and with external organizations including public officials, trade associations and other relevant parties.
  • Possesses unquestionable integrity and a sense of confidence, balanced with humility
  • Experience in leading external organization topic teams such as PhRMA, PDA, etc. preferred
  • Recognized as a speaker at internal meetings / conferences on current Quality / CMC topics.
  • Excellent English communication skills both written and oral, and presentation skills
  • Appropriate cultural awareness and ability to work effectively with those from other countries, particularly the emerging market areas in which Amgen is interested.
  • Ability to develop and maintain data bases

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, 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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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