Regulatory Labeling Contractor

Location
Tarrytown, New York
Posted
Nov 12, 2021
Ref
REGEA0026R4167
Required Education
Doctorate/PHD/MD
Position Type
Full time

SUMMARY/POSITION OBJECTIVE:

The Regulatory Labeling contractor will gain an appreciation for the role of the Regulatory Labeling Strategy Lead and Regulatory Labeling Operations Lead within Regulatory Affairs, and the end‐to‐end labeling life-cycle. Under the direction of Labeling Leads, the Contractor will contribute to the development of labeling strategies in line with product regulatory strategies to support the development of global labeling documents including Core Labeling documents ﴾Company Core Data Sheets ﴾CCDS﴿ and Core Instructions for Use ﴾Core IFU﴿﴿, United States Prescribing Information ﴾USPI﴿, EU Summary of Product Characteristics ﴾SmPC﴿, other Rest of World ﴾ROW﴿ labels, and associated patient labeling.

JOB DUTIES:  

Under direction of Regulatory Labeling Leads, the intern will:

  • Contribute to the development or maintenance of global labeling documents including Core Labeling documents ﴾Company Core Data Sheets ﴾CCDS﴿ and Core Instructions for Use ﴾Core IFU﴿﴿, United States Prescribing Information ﴾USPI﴿, EU Summary of Product Characteristics ﴾SmPC﴿, other Rest of World ﴾ROW﴿ labels, and associated patient labeling.
  • Research and conduct labeling intelligence searches in response to regulatory and/or business queries, to support development of regulatory/labeling strategies. 
  • Work on various tasks that support the daily operation of the Regulatory Labeling team such as development or management of various tools or trackers, annotating labeling documents to data, performing quality checks on labeling.

JOB REQUIREMENTS:

  • Graduate-level scientific degree candidate. PharmD or PhD candidate preferred.

  • Ability to make a commitment of ~15 hours/week throughout the university school year
  • Previous Biotech or Pharma industry exposure, preferably working with labeling.
  • Attention to detail and strong word processing skill.
  • Strong communication, teamwork and critical thinking skills
  • Ability to work in a fast paced-environment