About the role
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.