Policy Senior Manager

Lets do this. Lets change the world. The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgens goals and priorities, by engaging externally with regulators, industry trade associations, and patient advocates, along with internal subject matter experts across Amgen. In this vital role you will support the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will report to the Amgens U.S. Lead for Global Regulatory Policy and Intelligence.

Key Responsibilities

• Promotes internal awareness of key regulatory policy activities and coordinates Global Regulatory Policy communications across Amgen functions
• Prepares presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.
• Investigates policy research questions on key policy topics and determine the implications of emerging regulatory developments.
• Analyzes regulatory guidances and other regulatory policy documents to inform policy strategies and positions.
• Supports the development of Amgen regulatory policy positions and strategies.
• Partners with policy leads and subject matter experts to develop whitepapers, policy analysis documents, and advocacy materials on priority policy issues.
• Plans and help manages projects for agreed upon policy objectives under the direction of in partnership with policy lead(s) and management.

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 or 2 years of regulatory experience

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OR

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Masters degree and 4 years of related experience

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OR

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Bachelors degree and 6 years of regulatory experience

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OR

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Associates degree and 10 years of regulatory experience

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OR

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High school diploma / GED and 12 years of regulatory experience

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Preferred Qualifications

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Doctorate or Masters degree (scientific area)and 6 years of directly related regulatory policy experience, including knowledge of FDA or EMA, or international regulators.

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Bachelors degree (scientific area) and 8 years of directly related experience

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In-depth regulatory experience in the U.S.

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In-depth knowledge of U.S. legislation and regulations relating to medicinal products.

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A strong team player with a demonstrated track record of working collaboratively across functional areas.

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Strong oral and written communication skills.

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Strong interpersonal, problem solving, and conflict resolution skills.

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Demonstrated ability to work well with people at all levels of an organization in demanding situations with a positive attitude, tact, diplomacy, and respect.

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Demonstrated ability to work in a fast-paced environment while retaining a high attention to detail and quality.

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Excellent organizational, process and project management skills.

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Strong computer skills including experience with MS Office, Smartsheet, and SharePoint.