Howard University College of Pharmacy strives to be a premier University in teaching, learning, research, leadership and service locally and globally. We value diversity, integrity, professionalism, collaboration, cultural competence, and a commitment to excellence.

BASIC FUNCTION:   

The purpose of this post-doctoral fellow position is to provide unique professional training within the biopharmaceutical industry. Fellows will have the opportunity to gain pedagogical, administrative, business, and research developmental experiences through one-year or two-year fellowships at Howard University and sponsor companies. The fellow can gain multi-faceted training working on various projects within (a) academic (b) clinical administration (c) corporate, and/or (d) regulatory settings. In addition to professional development training at Howard University, fellows have opportunities to work alongside professionals at leading biopharmaceutical companies, FDA, and hospitals which prepares them to address real-world challenges to make an impactful difference in patients’ lives.

NATURE AND SCOPE:              

One and two-year fellowships for candidates of promise with a Pharm.D. or PhD degree who have a demonstrated history of excellence, possess excellent written and oral communication skills, are coachable and possess raw leadership talent are encouraged to apply.

At Howard University, fellows will have access to professional development and scholarly training in project management, fundamentals of leadership, self-development, management, and teaching along with clinical administration rotations in hospital settings depending on the area of focus. Fellows are expected to earn a PMP (Project Management) certificate, publish in their area of focus and develop/teach a continuing education or course in an area of their specialty. We provide coveted opportunities across academic, biopharmaceutical, clinical, corporate, and regulatory spheres, thereby nurturing solid groundwork essential for prosperous future careers in C-suite leadership positions within the biopharmaceutical industry.

Depending on the fellowship track and sponsor company, specialized professional training within the biopharmaceutical industries in various functional areas within the U.S. and Global teams across, but not limited to, research & development, medical affairs, regulatory, and commercial organizations. 1-year fellowship track: Medical Affairs 2-year fellowship track (see hiring manager for updates): Clinical Science & Operations; Medical Affairs; Medical Information; Pharmacovigilance, Government Affairs, Regulatory Affairs, Research & Development

PRINCIPAL ACCOUNTABILITIES:                

The fellow is a professional in training employed by Howard University and a contractor of the sponsor company to support cross-functional teams on various projects aligned with the fellow’s interest and business needs. Objectives vary based on area of focus. Those listed below are not all-encompassing:

• Understand the roles and responsibilities of a Pharm.D./PhD in the departments the Fellow rotates through.
• Continues to expand his/her 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. Writes, coordinates, analyzes, and/or reviews comments on medical, regulatory, or legislative initiatives and guidance.
• Supports interactions on policy and advocacy issues, including building relationships with key decision-makers.
• Supports implementation of strategic and tactical plans to initiate medical/pharmaceutical/regulatory changes/evolution's.
• Project manages implementation of medical/regulatory policy strategies by developing workplans, coordinating stakeholder outreach, synthesizing input from SMEs, managing communications and liaising with contractors and vendors as needed.
• Analyzes the regulatory environment. Communicates 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.
• Performs other professional developmental activities as assigned by the Program Director

CORE COMPETENCIES:           

• Knowledge building
• Collaborates ? Communicates Effectively
• Decision Quality
• Drive for Results
• Ensure Accountability
• Functional Knowledge
• Leads without Authority
• Manages Ambiguity
• Manages Complexity
• Stakeholder Focus