Pharmaceutical Industry and Education Fellow – Incyte Global Regulatory Affairs (2 year)

Position Title:

Pharmaceutical Industry and Education Fellow – Incyte Global Regulatory Affairs (2 year)

Time Type:

Full time

Position Summary and Qualifications:

This is a 2-year post-graduate training program providing advanced skill training in a variety of functions, including Global Regulatory Affairs.

This fellowship prepares individuals to pursue a career in the pharmaceutical industry.

Weekly responsibilities are split between Saint Joseph’s University (20%) and Incyte (80%).

This two-year fellowship provides the fellow an opportunity to contribute to the development of strategies and plans to advance Incyte products through the regulatory review and approval process globally. Our growing, diverse portfolio provides a hands-on opportunity to learn and contribute to the development and delivery of products to address significant unmet medical needs. Throughout this program, the fellow will develop skills and gain experience in key regulatory functions to enable them to embark on a career within Regulatory Affairs.

The fellow will successfully complete projects related to industry, the fellowship program, and teaching responsibilities.

It is expected that as the fellow progresses through the program, the individual will be able to practice with increasing levels of independence.

NOTE - ABOUT UPLOADS

All applicants should include the ALL of following attachments into the "Resume/CV" field of their application: a letter of intent; a curriculum vitae; unofficial college transcripts, both undergrad and professional; a document listing (3) references with their name, degree(s), title, email address and phone number for each reference; and a writing sample (e.g., example of drug information response; other non-peer reviewed materials are acceptable. No posters, slide presentations, group activities, or peer reviewed publications). The online application system only allows for 5 total attachments, please consider this as you upload your attachments.

Fellowship Objectives

• Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
• Develop professional responsibility and enhance leadership presence.
• Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
• Strengthen ability to critically evaluate, interpret, synthesize, and communicate scientific information.
• Instill knowledge of laws, compliance regulations, and guidance’s pertaining to medical and regulatory affairs
• Advance critical thinking skills through industry-based projects and cross-functional teamwork. 
• Strengthen leadership and professionalism through participation in academic and industry initiatives.
• Apply and communicate clinical knowledge to projects and project teams.

Essential Duties & Responsibilities

Industry-based Responsibilities:

Regulatory Strategy:

• Develop an understanding of federal laws, regulations, and guidance that form regulatory strategy
• Contribute to Investigational New Drug (IND) Applications, New Drug Application (NDA), Clinical Trial Applications (CTA), and post-marketing submissions
• Collaborate with cross-functional teams in the oncology and inflammation/autoimmune disorder portfolios

Promotional Regulatory Affairs:

• Develop an understanding of federal laws, regulations, and guidances that guide the promotion of prescription drugs and biologics for healthcare professionals and consumers
• Contribute to the development and review of healthcare professional and consumer marketing and educational materials, as well as contribute to the review of Medical Affairs materials
• Partner with marketing, Medical Affairs, and legal representatives during review of assets
• Assist with FDA submissions

Regulatory Labeling:

• Develop an understanding of regulations and guidance that steers the development of and updates to product labeling for healthcare professionals and patients
• Through engagement and collaboration with cross-functional subject matter experts, support the development and maintenance of the Company Core Data Sheet and local product labeling documents
• Contribute to the development of labeling tools and processes to expand the capabilities and efficiencies of the labeling team

Additional Experience:

• The Fellow will meet with other specialty areas in GRA, including CMC and Regulatory Operations, to develop an understanding