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.

Regulatory Promotion Reviewer - Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public.

This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.

Key activities include:

• Promotional review committee experience in evaluating proposed pieces and supporting evidence
• Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen
• Update the Promotions group on new learning’s and key takeaways from courses, congresses, and tradeshows
• Mentor Senior Associate and Manager level reviewers
• Assesses promotional programs against Regulatory requirements
• Identifies changes required to meet Promotional Regulation

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree and 2 years of related experience

Or

Master’s degree and 4 years of related experience

Or

Bachelor’s degree and 6 years of related experience

Or

Associate’s degree and 10 years of related experience

Or

High school diploma / GED and 12 years of related experience

Preferred Qualifications:

• Serves as an advertising and promotions technical authority within the organization
• Experience in reading, understanding, and applying promotional regulations to a constantly changing environment
• Experience in an environment which requires extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment
• Experience understanding and interpreting data/information and its practical application
• Leadership
• Strategic focus
• Collaboration
• Independence
• Clinical knowledge/understanding
• Analytical judgment
• Negotiation/persuasion skills
• Coaching and mentoring skills
• Project management skills
• Problem solving skills
• Time management skills
• Organization

Thrive

What you can expect of us

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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.

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Salary Range

139,680.00 USD - 166,362.00 USD