Temporary -Risk Management Fellow

Location
Tarrytown, New York
Posted
Mar 27, 2018
Ref
12613BR
Required Education
Doctorate/PHD/MD
Position Type
Contract
Position Summary

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 (R.M.)-related roles within the biopharmaceutical industry, which will serve as the foundation. The R.M. fellowship is for highly motivated individuals seeking to build a career in the industry, specifically in R.M./Regulatory Affairs, and outside of a traditional academic, health-system or retail environment.
The fellowship will serve as the foundation for the potential roles within R.M. and cultivates technical and non-technical skills through diverse cross-functional experiences, ongoing mentorship 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 candidates from accredited College of Pharmacy programs or very early career professionals (1-2 years maximum) with a PharmD degree.

Duties:

Core Rotations
• 3-month rotations that can be extended at the discretion of participant, program sponsor and/or program manager

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

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

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

Pharmacoepidemiology

Additional Rotations: 1 month rotations that can be extended at the discretion of participant, program sponsor, and/or program manager
• Quality and Compliance
• Vendor and Case Processing Management
• Clinical Program PV Management

Requirements:

High academic standing
No GPA limitations

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.

Requisition Number: 12613BR