Temp - Clinical Fellow RM

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The objective of the fellowship is to provide training and hands-on experience in a variety of Risk Management (RM) related roles within the biopharmaceutical industry, which will serve as the foundation. The RM fellowship is for highly motivated individuals seeking to build a career in the industry, specifically in RM, and outside of a traditional academic, health-system, or retail environment.
The fellowship will serve as the foundation for the potential roles within RM and cultivated technical and non-technical skills through ongoing mastership and targeted training. The overall objective of the fellowship is to convert participants into full-time Regeneron employees, based on performance and at the discretion of Regeneron management.
Newly graduating Post-doctoral candidate from an accredited College of Pharmacy program or very early career professional (1-2 years max) with a PharmD degree

Job Duties:
Essential Functions required for the job. List both technical and managerial requirements if applicable.

Primary responsibilities will be direct involvement in the following:

• Regulatory Reports
o 4 (or more) Development Safety Update Reports (DSURs) including Benefit-Risk

• Assessments
o 1 (or more) Periodic Safety Update Reports (PSURs) or
o 1 (or more) post-marketing Adverse Event Reports (PAERs) or
o 1 (or more) Risk Management Plans (RMPs) or o 4 (or more) development RMPs(dRMPs)

• Signal Detection and Management
o 6 (or more) Safety Monitoring Team (SMT) Meetings
o RM monthly reports
o Signal Tracker

• Pharmacoepidemiology
Additionally, at the discretion of the program manager and the participant and depending on work needs, rotations may be offered in the following Pharmacovigilance (PV) areas:

• Quality Compliance

• Vendor and Case Processing Management

• PV Planning

Requirements:

High academic standing (no GPA requirement)

Impeccable skills as follows:

• analytical written/verbal problem solving skills, organizational leadership, as demonstrated in internships, school activities, special classroom projects, rotations

• Solid internship/program work experiences across different industries -Some bio-pharmaceutical experience is preferred

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.