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 of the contributions needed for small and large molecule development and regulatory submissions and systems.

University-Based Responsibilities:

• Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation for pharmacists
• Actively participate in professional development seminars and workshops designed to enhance professional growth and leadership
• Contribute to the successful functioning of the fellowship program, such as facilitating student outreach, recruitment, marketing, social media, team building, etc.

Secondary Duties & Responsibilities

As a training program, all the duties and responsibilities are considered primary and necessary for successful completion of the fellowship.

Minimum Qualifications

Required:

• Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy (by the start of the fellowship program) OR a PhD in a relevant scientific/life sciences field (e.g., immunology, pharmacology, cancer biology.)
• It is expected that the fellow will be able to commute to both the university and the company to fulfill fellowship requirements.

Preferred:

• Computer skills: Microsoft Office, email and calendar proficiency
• Sufficient technology aptitude to learn new technology systems, including virtual conferencing if necessary
• Medical writing proficiency
• Communication skills, including formal presentations
• Ability to work cross-functionally with a diverse team

Physical Requirements

This position does not require lifting or pulling as part of the day-to-day activities.

Unusual Work Hours

• Throughout the year, there will be periodic times when the fellow will be responsible for attending conferences, webinars or meetings outside the usual work hours, either in the evenings or on the weekends.
• Travel may be required to represent the fellowship at various recruitment sessions, such as university career fairs and professional conferences.
• The fellow will be required to split their time between the university and the industry site, currently located in Chads Ford, PA, approximately 20 miles from the university.

Required Documents: See Note At The Top Of This Listing

• Curriculum vitae / resume
• Letter of intent
• Example of drug information response (other non-peer reviewed material is acceptable)
• Unofficial transcript(s)
• Contact information for 3 references

Saint Joseph’s University is a private, Catholic, Jesuit institution and we expect members of our community to be knowledgeable about – and to make a positive contribution to – our mission. Saint Joseph’s University is an equal opportunity employer that seeks to recruit, develop and retain a talented and diverse workforce. The University is committed to the diversity of its faculty and staff so that our students, our disciplines and our community as a whole can benefit from the multiple perspectives it offers. The University seeks qualified candidates who share our commitment to equity, diversity and inclusion. EOE

Saint Joseph’s University prohibits discrimination on the basis of sex in its programs and activities, including admission and employment, in accordance with Title IX of the Education Amendments of 1972. The Title IX Coordinator is responsible for overseeing compliance with Title IX and other civil rights laws and regulations. To contact the Title IX Coordinator, e-mail titleix@sju.edu, visit Campion Student Center suite 243, or call 610-660-1145. To learn more about the University’s Title IX policies, the process for filing a report or formal complaint of sex discrimination, sexual harassment, or other form of sexual misconduct, and the University’s response to reports and/or formal complaints, please visit www.sju.edu/titleix. Inquiries may also be directed to the Federal agency responsible for enforcing Title IX, the U.S. Department of Education Office for Civil Rights.

Pay Transparency & Benefits Overview

Please click to read more about the university's approach to pay and benefits transparency. Adjunct instructor compensation can be found in the article. Otherwise, an estimated pay range is listed below. This position's estimated pay range is:

$61,800.00 - $74,100.00