Job Details
Pfizer — Hub Labeling Senior Associate
Data Analytics
Job Description
Pfizer — Hub Labeling Senior Associate
Location: Cairo, Egypt (Hybrid)
Level: Mid-level Associate
Industry: Artificial Intelligence, Healthtech, Machine Learning, Biotech, Pharmaceutical
Role Overview
Manage and execute content management of Local Product Documents (LPDs), Local Label Documents (LLDs), and Patient Leaflets (PLDs) for nationally registered products across multiple countries/regions. Provide labeling support in collaboration with Hub Labeling Managers, ensuring compliance with regulatory and company standards.
Key Responsibilities
- Execute labeling projects of moderate complexity under senior manager guidance.
- Produce LPDs, LLDs, PLDs based on regulatory principles and source documents.
- Create labeling documentation for Health Authority submissions (track changes, annotated labels, comparison tables).
- Perform quality control (QC) checks on colleagues' work.
- Identify process and system improvements for labeling activities.
- Meet productivity, quality, and compliance targets.
Qualifications & Skills
- Knowledge of labeling principles, local and global regulatory guidelines.
- Strong proficiency in MS Excel, MS SharePoint, MS Access, and other business systems.
- Fluent in written and spoken English; Arabic language skills advantageous for QC of medical/scientific content.
- Understanding of SOPs and processes to ensure quality and compliance.
- Attention to detail and problem-solving ability.
- Ability to quickly learn new software and regulatory standards.
Experience
- Degree in Life Sciences, Pharmacy, or equivalent professional experience.
- Experience with registration, development, maintenance, and commercialization in Regulatory Affairs, especially from a Country office or Regional strategy perspective.
- Ability to assess regulatory impact on product labeling strategies.
- Familiarity with clinical variations and regional/local regulatory labeling guidance.
- Demonstrated project management and collaborative skills across cultures and locations.
Organizational Relationships
- Reports to International Labeling Team Lead.
- Collaborates with Clinical Research Scientists, Global Regulatory Sciences, Global Regulatory Operations, and other platform lines.
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