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Position Title:

Pharmaceutical Industry and Education Fellow - CSL Behring Medical Information / Medical Affairs (2 year)

Time Type:

Full time

Position Summary and Qualifications:

This is a 2-year post-graduate training program providing in-depth training and hands-on experience in both medical information and medical affairs.

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

Weekly responsibilities are split between Saint Joseph's University (20%) and CSL Behring (80%).

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.

This 2-year fellowship curriculum provides an introduction to the pharmaceutical industry by learning the functions of Medical Affairs within organization at CSL Behring. The fellows will spend the first year developing essential skills in Medical Information, which include the critical evaluation of scientific data and the creation of scientific content. During the second year, fellows will learn the roles of the broader Medical Affairs team with a focus on medical strategy and tactics. In addition, the fellows will have an opportunity to choose a rotation with either the Medical Outcome Specialist or Global Regulatory Affairs teams. The program also offers opportunities for conference attendance, refining written and oral communication skills and cross-functional collaboration.

All applicants should include ALL the 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 (eg, example of drug information response; other non-peer-reviewed materials are acceptable). 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:

Medical Information (Year 1)

• Gain therapeutic knowledge of all products in CSL Behring's portfolio within Transplant/Immunology, Hematology, Immunoglobulin, and Acquired Bleeding therapeutic areas
• Respond to unsolicited Medical Information requests from healthcare professionals and patients
• Create and update standard response letters and enhance skills in literature retrieval and analysis
• Review promotional materials in collaboration with legal, regulatory, and marketing colleagues to ensure medical accuracy, fair balance, and appropriate content/context
• Collaborate with Medical Affairs colleagues in the review of slide decks and other medical resources
• Attend scientific congresses and provide support for the Medical Affairs booth
• Identify Medical Information insights and trends in inquires received

Medical Affairs (Year 2)

• Review medical grants such as Investigator Initiated Studies and Independent Medical Education in alignment with medical strategy
• Contribute to creating valuable scientific information through publication by collaborating with experts and thought leaders
• Assist in creation of medical educational materials such as presentations, videos, and conference materials while managing third-party vendors
• Assist in coordination and facilitation of advisory boards/ steering committees
• Learn how to manage US Medical Affairs therapeutic area budgets and allocate resources appropriately
• Identify insights to address gaps that drive medical strategy and content creation

Multidisciplinary Rotations (Fellow will choose 1):

Medical Outcomes Specialist (MOS) Rotation

• Develop an understanding of the MOS role through didactic and experiential learning activities
• Collaborate with managed care functions across the organization learning about their roles and responsibilities
• Gain a deeper understanding about the dynamics and stakeholders of the U.S. Healthcare System (HCS)

Global Regulatory Affairs Rotation:

• Develop an understanding of the roles and responsibilities within global regulatory affairs, including labeling, global and regional regulatory strategy, regulatory science and policy, and promotional review
• Gain a deeper understanding of global regulations and guidances related to drug development and marketed products, while gaining insights into global regulatory health authorities such as the FDA and EMA
• Learn and support regulatory submissions including Investigational New Drug (IND) applications, Biologics License Applications (BLA), and post-marketing submissions

University-based Responsibilities:

• Completion of a one-year Teaching and Learning Curriculum 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)
• 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.

Required Documents

• 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.

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