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WSR/ Hub Labeling Manager, Associate(1yr) ä¿ë °ø°í

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http://www.pfizer.co...

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Job description

¡ÛResponsibilities
¡Û This position reports to the locally based Regional Labeling Head or a senior manager in the ILG organisation.
- 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



¡ÜDesired Skills and Experience

¡ÛQualifications
¡Û Technical Skill Requirements
- Has fundamental knowledge of the principles and concepts of labeling.
- Basic 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 ¡Ûmaintaining 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 ¡Ûquality and compliance of deliverables
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access





¡Ü
Education

¡Û Life sciences, pharmacy graduate or equivalent



¡Ü Experience

¡Û ''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 is advantageous especially with the perspective of the implications of a CDS on LPDs
¡Û Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
¡Û Knowledge of global/regional regulatory guidelines and requirements is preferable
¡Û Knowledge of Clinical Variations preferred
¡Û Proven strength in logical, analytical and writing ability essential
¡Û Demonstrated project management, attention to detail and problem solving skills required.



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Á¢¼ö¹æ¹ý: https://www.linkedin.com/jobs2/view/16525298?trk=jobs_jig_jobs  


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