Job Description

Labeling Strategist
Job Number: 21-03199
 
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Labeling Strategist for our client in Lawrenceville, NJ.

 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Responsibilities:
  • Initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure
  • Provide labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC
  • Ensure labelling complies with the CCDS and deviations are identified and managed appropriately
  • Reviews country labels to ensure labeling compliance
  • Assist in the review and response of HA queries relating to labeling; Version, archives and distributes final PI for internal use
  • Manage electronic archiving of draft mock-ups and label texts, and packaging artwork, including version control and archiving
  • Support Regulatory inspections and internal audits
  • Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of LifeSciences with at least 2 years of Labeling / Regulatory Experience
Qualifications:
  • Good Understanding of Drug Development and Commercialization of prescription medicines
  • Ability to understand regulatory implications of product strategy related to labeling development, assessment and management
  • Ability to develop strong and positive working relationships across diverse teams and within a global environment
  • Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making
  • Experience in managing medium complex projects
  • Excellent verbal and written communication skills
  • Keen attention to detail and accuracy
  • Ability to assimilate clinical and scientific information and present it in a concise manner
  • Ability to think creatively and good excellent problem-solving skills
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro 


If interested, you may contact:
Maria Castañeda
maria.castaneda@eclaro.com
6463571235
Maria Castañeda | LinkedIn
 
 

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

 

Application Instructions

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