QUALIFICATIONS AND JOB DESCRIPTION
Primary Responsibilities:
Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled Maintenance of workflow management tools and mailboxesAd hoc support for labeling deliverablesProof-reading of labeling textTechnical Skill Requirements:
- Knowledge of the principles and concepts of labeling
- Basic knowledge of key regulatory and labeling principles and localregulations
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliancefigures
- Fluency in English language important however multi-language skills are advantageous
- Understanding of the importance of Standard Operating Procedures (SOPs),systems and processes in underpinning quality and compliance ofdeliverables
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MSAccess
Qualifications:- Life sciences, pharmacy graduate or equivalent (desirable); or equivalentrelevant professionalexperience
- Some ‘Hands on’ registration experience associated with development,maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products) ispreferred
- Demonstrated ability todevelopstrongandpositiveworkingrelationshipsacross multiple cultures andlocations
- Demonstration of attention to detail and problem-solving skillsrequired