JOB SUMMARY

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 RESPONSIBILITIES

• 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.

SKILLS

• 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, and understands importance of systems in maintaining high compliance figures.
• Fluency in English language important however multi-language skills are advantageous.

• Clear and effective written and verbal communications.

• Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
• Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
   

QUALIFICATIONS

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.

EXPERIENCE

• 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)

  
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs