LOM - International Associate (Labeling)

• Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes.
• Ad hoc support for labeling deliverables.
• Proof-reading of labeling text.
• System data integrity and quality checks.

• Knowledge of the principles and concepts of labeling.
• 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 Standard Operating Procedures (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

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

• 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 the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs.

Pfizer