Policy Director
AmgenUs - washington d.c.Update time: December 13,2021
Job Description

Career Category

Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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 reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Policy Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business. The scope of leadership responsibilities span policy topics and regions; Engages on cross-functional teams to develop strategic/long-term plans for the development and implementation of policies. Also interacts regularly with regulatory authorities, and industry and professional associations at the policy level.

  • Ensures that Amgen's regulatory, safety, and R&D policy positions are successfully represented to advise policy development and implementation
  • Fosters a reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound policies
  • Leverages key relationships, internally and externally (e.g. FDA, EMA and national authorities, as well as industry associations) to advance Amgen's position related to regulatory and safety policy
  • Provides internal partners (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic perspective
  • Supports senior leadership in selecting issues, establishing priorities, and developing and completing regulatory policy advocacy plans
  • Assists in creating vital infrastructure and processes for developing the regulatory policy function
  • Ensures direct and dotted line staff are compliant with required training and SOPs, and conducts an annual review of staff training records for direct line reports

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The industry professional we seek is a diligent and driven policy partner with these qualifications.

Basic:

  • Doctorate degree and 4 years of directly related experience, OR
  • Master’s degree and 7 years of directly related experience, OR
  • Bachelor’s degree and 9 years of directly related experience

Preferred:

  • Comprehensive knowledge of the biopharmaceutical or medical device industry, drug development, and regulatory and/or business strategies and plans.
  • Knowledge of the specific domains within Regulatory and Safety Presentation and interpersonal communication skills
  • Relationships with industry collaborators (e.g., trade associations, biopharmaceutical companies, FDA, EMA, other national competent authorities)
  • Knowledge of Amgen Commercialization Process is a plus

Thrive

What you can expect of us

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.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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

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