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.
- 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