Job Summary

Associate

Is responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes and associated technical support are also an essential part of the role.

Job Responsibilities

Associate

• Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled. Maintains workflow management tools and mailboxes.

• Provides ad hoc support for labeling deliverables.

• Proofreads labeling text.

• Performs system data integrity and quality checks.

Qualifications / Skills

Qualifications and skills necessary for performance of responsibilities, including education, relevant experience, licenses, certifications and job-related technical and managerial skills.

Skills - Associate

• Knowledge of the principles and concepts of labeling.

• Knowledge of key regulatory and labeling principles and local regulations.

• Proficiency in systems consistent with business expectations and understanding of their importance in maintaining compliance.

• Fluency in English is important; multilingual skills are advantageous.

• Clear and effective written and verbal communication.

• Understanding of the importance of SOPs, systems and processes in supporting quality and compliance.

• Experience working with structured data in enterprise databases, Microsoft Excel, Microsoft SharePoint and/or Microsoft Access.

Qualifications

Qualification

Associate

Life sciences/pharmacy graduate or equivalent professional experience

Preferred

Advanced academic qualification, such as PhD

Not Required

Experience

Experience Requirement

Level Requirement

Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.

All levels - Required

Demonstration of attention to detail and problem-solving skills.

All levels - Required

Proven technical aptitude and ability to quickly learn new software, regulations and standards.

All levels - Required

Hands-on registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products), preferably from a country office or Regional Regulatory Strategy perspective, including implications of a CDS on LPDs.

Associate - Preferred;

Organizational Relationships

Primary groups or key roles with which this role interacts regularly, including external interactions as appropriate.

• Reporting relationship to Director Lead International Labeling Operations.

• Partners with Pfizer PCOs, GRS groups, GLAAM and other platform lines as required.

• Supports global, GRS and GLAAM initiatives as required.

Life sciences or pharmacy graduate or equivalent professional experience; knowledge of labeling and regulatory principles; proficiency in Microsoft Excel, SharePoint, Access; fluency in English; attention to detail and problem-solving skills.

Key Responsibilities

• maintaining labeling documentation
• supporting labeling deliverables
• performing data integrity checks

Skills & Tools

Microsoft Excel, Microsoft SharePoint, Microsoft Access, GDMS, PfLEET

Job Details

• Category: Research and Development (R&D)
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Egypt
• Languages: English

About ClinChoice

A global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. — Industry: Research and Development