Labeling Services Analyst in Abbott Park, IL

Position Title: Labeling Services Analyst

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

Minimum Education Required:

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

Minimum Experience Required

• 4+ years of pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent demonstrated knowledge strongly desired
• 3+ 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
• Consulting and Glemser xmLabeling experience is a plus

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 in the global labeling repository (GLS)
• Performs quality control of information entered by Analysts into the global labeling repository (GLS)
• Performs proactive data remediation in global labeling repository (GLS) to ensure accurate and up to date labeling information is captured
• Partners with Registration Management and Regulatory Information Services to ensure accurate current and historical representation of product registrations, withdrawals, submissions and approvals in the global labeling repository (GLS)
• Partners with Global Submissions Operations to ensure all affiliate labeling needed for regulatory submissions is available in the global labeling repository (Pending Submissions)
• Provides labeling process training to global affiliate sites
• Assists to establish process and standards related to the global labeling repository (GLS)
• Functions as subject matter expert for global labeling and related functional areas
• Communicates global labeling regulatory requirements as it pertains to the global labeling repository (GLS), to department and other cross-functional areas
• Participates on cross-functional and cross-divisional teams for process improvement initiatives
• Assists in the development of labeling metrics per month utilizing Excel

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