Senior Manager, Regulatory Promotion & Material Compliance
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Job Description
Regulatory Affairs Sr Manager ensuring truthful communication and formulations for product promotions at Amgen. Leading compliance efforts by interpreting FDA regulations and guiding promotional programs.
Responsibilities:
- Provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment
- Ensure truthful and non-misleading communication to health care community, patients, and the public
- Formulate and communicate the regulatory promotional position for approved and/or pipeline products
- 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
- Assess promotional programs against Regulatory requirements
- Identify changes required to meet Promotional Regulation
Requirements:
- 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
- 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
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program
- stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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