Job Description

Clinical Labeling Specialist
Job Number: 21-09819
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Labeling Specialist for our client in New Brunswick, 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:
  • Responsible for the creation and approval of clinical label text for Client studies through effective management of assigned projects. Generates label text in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects
  • Liaises with responsible Trial Supplies Manager and regulatory approvers on aspects of clinical supplies packaging and labelling design and study requirements and resolves issues
  • Creates internal label proof(s). Ensures label proofs contain all information as identified in approved label text specifications and complies with current procedures
  • Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Identifies and reports issues to appropriate levels of management in a timely manner
  • Working with approved vendors to procure label text translation and labels proofs as applicable
  • Reviews existing procedural documents
  • Works cross-functionally with individuals and project teams in various areas
 
Qualifications:
  • Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment
  • Strong project management skills and detail oriented
  • Possesses solid oral and written communication skills
  • Good decision making and organizational skills
  • Demonstrates ability to effectively communicate ideas and to influence others to achieve results
  • Ability to understand and apply regulatory and CGMP principles
  • Knowledge of ERP/MRP systems and supply chain principles
  • Eager to learn and continuously improve
 
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:
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | 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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