ClinChoice - Global Labeling, Artwork, & U.S. Advertising & Promotion Consultant
Requirements
• Qualifications and skills necessary for performance of responsibilities, including education, relevant experience, licenses, certifications and job-related technical and managerial skills. • 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. • Qualification • Associate • Life sciences/pharmacy graduate or equivalent professional experience • Advanced academic qualification, such as PhD • Level Requirement • Level Requirement • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations. • Demonstration of attention to detail and problem-solving skills. • Proven technical aptitude and ability to quickly learn new software, regulations and standards. • 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.
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.
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