Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
RemoteUnited States
Job Summary
Provide strategic direction for product and disease communications by interpreting the current FDA regulatory environment to ensure truthful and non-misleading communication to healthcare communities, patients, and the public. Formulate and communicate the regulatory promotional position for approved and/or pipeline products. Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen. Mentor Senior Associate and Manager level reviewers while assessing promotional programs against regulatory requirements. Identify changes required to meet promotional regulations and update the Promotions group on new learnings from courses, congresses, and tradeshows.
Required Qualifications
- Doctorate degree and 2 years of related experience
- Master's degree and 4 years of related experience
- Bachelor's degree and 6 years of related experience
- Associate's degree and 10 years of related experience
- High school diploma / GED and 12 years of related experience
Desired 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
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