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Hub Labeling Associate is responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled. Maintains workflow management tools and mailboxes and associated technical support.
Job Responsibility:
Supports Hub Labeling Manager (Manager) by maintaining system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
Maintenance of workflow management tools and mailboxes
Provides ad hoc support for labeling deliverables
Performs QC of labeling text
Monitors system data integrity and quality checks
To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system
Requirements:
Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Basic knowledge/understanding of the principles and concepts of labeling
Basic knowledge of key regulatory and labeling principles and local regulations
Proficient in use of systems consistent with business expectations
Fluency in English language
Clear and effective written and verbal communications
Understanding of the importance of SOPs, systems and processes
Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations (Preferred)
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs (Preferred)
Nice to have:
Multi-language skills are advantageous
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations (Preferred)
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs (Preferred)