Hub Labeling Manager 12m at New York

Job Description

The Hub Labeling manager (HLM) is responsible for executing the content management of local product documents (LPDs) for their assigned products across multiple countries/regions. This role will keep up to date with regional labeling regulations. Additionally the role will oversee content across all labels for their assigned products in their assigned regions and drive consistency of content and messaging wherever possible. This role will focus on and be responsible for the production of labels referred to as LPDs, the associated Local Language Documents (LLDs); any Patient Information Leaflets (PILs) and any Technical leaflets regardless of registration status/procedure across the globe. HLMs across the regional areas will work together to ensure that labeling is updated on a timely basis according to internal SOPs and external regulatory requirements. Where appropriate, the HLM will seek advice from identified roles when authoring text that deviates from the core. This role will interface with Global Labeling Leads, PCO colleagues, PSSR Authors, Global/Regional Medical TA Leads, Submissions Specialists and Labeling Operations Specialists in the delivery and management of labeling text through appropriate processes and systems to assure the timely submission and ultimate approval of Client product labeling.ORL

Job Requirements

 
Country: USA, State: New York, City: New York, Company: InVentiv Health.