+1 908 704 8843      270 Davidson Avenue, Suite 103, Somerset, NJ 08873
Job Description

Labeling Services Analyst

Name of Functional Area/Department: Registration and Labeling Compliance Operations

Minimum Education Required

  • Bachelor degree preferred in a scientific, engineering and/or computer science discipline.

Minimum Experience Required

  • 2+ years of pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent demonstrated knowledge strongly desired.
  • 1+ years of experience with electronic document management technology or equivalent demonstrated knowledge
  • Demonstrated analytical capabilities.
  • Demonstrated strong communication skills, effective presentation skills, negotiation and influencing skills.

Primary Function

  • Manages the entry and compliance of data into the global labeling repository (GLS).

Major Job Responsibilities

  • Liaises with global affiliate sites to maintain up to date global labeling information into the global labeling repository (GLS).
  • Performs quality control of information entered into the global labeling repository (GLS).
  • May perform proactive data remediation in global labeling repository (GLS) to ensure accurate and up to date labeling information is captured.
  • Partners with Global Submissions Operations to ensure all affiliate labeling needed for regulatory submissions is available in the global labeling repository (Pending Submissions).
  • May provide labeling system guidance and support to global affiliate sites.Communicates global labeling regulatory requirements as it pertains to the global labeling repository (GLS) within functional areas.
  • Participates on global labeling projects and initiatives as pertaining to process improvement initiatives may support labeling metrics per month utilizing Excel