Pharma Post Doctoral Fellowship

Pharma Post Doctoral Fellowship

Requirements

• Possess a Doctor of Pharmacy degree or PhD from an accredited College/University
• Be licensed or eligible for licensure in the District of Columbia by start of the fellowship
• Provide a compelling letter of intent
• Provide a complete academic transcript
• Provide a professional CV
• Provide 3 letters of recommendations

Responsibilities

• Support cross-functional teams on various projects aligned with the fellow’s interest and business needs
• Understand the roles and responsibilities of a Pharm.D./PhD in the departments the Fellow rotates through
• Continue to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs, biologics, and devices
• Gain working knowledge of laws, regulations and policies enforced by the FDA as they relate to the advertising and promotion of pharmaceuticals and devices
• Support interactions on policy and advocacy issues, including building relationships with key decision-makers
• Support implementation of strategic and tactical plans to initiate medical/pharmaceutical/regulatory changes/evolutions
• Project manage implementation of medical/regulatory policy strategies by developing work-plans, coordinating stakeholder outreach, synthesizing input from SMEs, managing communications and liaising with contractors and vendors as needed
• Analyze the regulatory environment and communicate specific regulatory trends, analysis, and intelligence to various internal functions
• Provide scientific and clinical support for marketed products and products in development, and appropriately communicate to internal and external customers
• Build therapeutic expertise and develop verbal and written communication skills necessary to engage with internal and external stakeholders
• Advise appropriate departments within the company of regulatory requirements
• Review draft and final advertising/promotional materials, ensuring full regulatory compliance of all promotions for all assigned products, including the submission of promotional materials to the FDA
• Perform other professional developmental activities as assigned by the Program Director

Preferred Qualifications

• Demonstrated history of excellence
• Excellent written and oral communication skills
• Coach-able
• Possess raw leadership talent