Pfizer: Strategic Labeling/US Regulatory Advertising and Promotion

OVERVIEW:

This SL/AP Fellowship is a unique program designed to provide customized and practical learning opportunities in specialized areas of Regulatory Affairs. The hands-on experience in both Global Strategic Labeling and US Regulatory Advertising & Promotion and collaboration with colleagues in diverse roles will provide the Fellow with the foundation for a strong career in the pharmaceutical industry.

WHO WE ARE:

A highly experienced Team of Regulatory specialists who have cultivated knowledge and acumen in the realm of pharmaceutical advertising and promotion. As the regulatory subject matter experts (SME), we work with our Legal, Medical, and Commercial colleagues to provide strategic regulatory guidance during the development of advertising and promotional materials for Pfizer's drug and vaccine portfolios in the United States. Our work helps ensure Pfizer’s communications with healthcare professionals, patients, and caregivers about its products are accurate, balanced, truthful, and not misleading. In concert with the material creators and other SMEs, we help ensure that communications about Pfizer1s products comply with internal policies, applicable laws, regulations, and industry standards.

JOB SUMMARY: 

Year 1 - Exposure to and hands-on experience in Global Strategic Labeling, including:

  • Develop comprehensive knowledge of labeling regulations and real-world applications of prescribing information for healthcare providers and patient leaflets.
  • Understand the type of scientific and regulatory data that support prescribing information and patient labeling.
  • Participate in the creation, revision, and maintenance of our Core Data Sheets, USPIs (US Prescribing Information) and EU SmPCs (Summary of Product Characteristics).
  • Research, analyze, and present on competitor labels and label precedent.
  • Support label negotiations with Health Authorities.
  • Provide support to ongoing label initiatives with internal and/or external partners.
  • Work with matrix teams and interact with the Subject Matter Experts (SMEs) such as Regulatory, Safety, Clinical, Medical, Commercial, Supply Chain, Chemistry Manufacturing and Controls, and Global Access Value
  • Gain experience from mentors with similar pharmacy background who have extensive labeling experience in the pharmaceutical industry.

Year 2 - Building on Year 1, exposure to and hands-on experience in US Advertising & Promotion, including:

  • Develop comprehensive knowledge of FDA laws, regulations, and guidance and their real-world application to a broad variety of advertising and promotional communications.
  • Develop strong skills: written and verbal communication, critical thinking, collaboration, problem-solving, time- management, business savvy, interpretation and application of promotional standards.
  • Collaborate with a diverse group of colleagues, including Marketing, Legal, Medical, and Labeling.
  • Developing an understanding of how promotional communications are utilized by Pfizer customer-facing colleagues, healthcare providers, patients, and caregivers.
  • Provide strategic regulatory assessment and advice for proposed advertising and promotional materials and activities.
  • Support the overall strategic and operational functions within US Advertising & Promotion.

APPLICATION REQUIREMENTS:

  • Curriculum Vitae
  • Letter of Intent
  • Official Transcript
  • 3 Letters of Recommendation 

ELIGIBILITY CRITERIA:

  • Graduated or will graduate with a PharmD. or Ph.D. from an accredited School or College of Pharmacy prior to the summer of 2025
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