会社名
非公開 No.RE181103
職種
医薬品:製造・生産管理・QC・QA
仕事内容
[Position Purpose]
The Labeling manager is responsible for executing the content management of non-complex local product documents (LPD), Local Label Documents (LLD) and Patient Leaflets for nationally registered products for their assigned products across multiple countries/regions. This role also provides associated labeling support to the rest of the ILG organization.

[Primary Responsibility]
・Contributes to the completion of moderately complex projects under the direction of more senior labeling managers
.・Utilize regulatory knowledge to produce noncomplex LPDs, LLDs and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
・Production of other labeling-related documentation for submission to Health Authority such as track change versions, annotated labels, comparison tables and annotated supportive documentation.
・Provides QC support to other labeling colleagues.
・Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
・Meets defined targets on productivity, quality and compliance, as set by and overseen by management
対象条件
[Tecnical Skill Requirement]
・Strong knowledge/understanding of the principles and concepts of labeling.
・Strong 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
年齢
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勤務地
東京

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