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Regulatory Labeling Associate
Ref No.: 18-00311
Location: Remote
Position Type:Contract
Experience Level: 2 Years
Start Date: 03/07/2018
Job Responsibilities:
  • Support the review and delivery of Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products and their associated Patient Labeling Documents.
  • Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
  • Consolidate labeling versions and Prepare comparison tables for labeling team discussions.
  • Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate
  • Manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents.
  • Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).
  • Responsible for updating related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
Job Requirements:
  • At least 0-2 years in a regulated environment; pharmaceutical labeling experience.
  • Ability to apply regulatory labeling guidance on formatting requirements.
  • Must have excellent computer skills, proficient with MS Word and similar applications.
  • Prepare submission ready documents.
  • Hyperlinking, pagination, Table of Contents (TOC) creation. 
  • Knowledge of Labeling and Document Management systems.
  • Bachelor's degree in life sciences preferred or equivalent practical experience.
  • Knowledge of global/regional regulatory guidelines and requirements important.
  • Excellent written and verbal communication skills essential.