Hub Labeling Manager

ROLE SUMMARY

This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or to a Senior Manager in International Labeling Group. The Hub Labeling Manager (HLM), Manager level, is responsible for executing the content management of Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets for nationally registered products for their assigned products across multiple countries/regions. The full range of labeling documentation may be produced.



ROLE RESPONSIBILITIES

This position reports to the locally based Regional Labeling Head or a Senior Manager in the ILG organisation.

• Utilize regulatory expertise to review, develop and deliver labeling documents such as the LPD, LLD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting advice or input from other functions when appropriate.

• Production of other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supportive documentation.

• The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as other complex revisions.

• For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and may provide support during regulatory agency questions.

• May coordinate labeling revisions when there is a regional, global or therapeutic area impact across multiple countries

• May mentor or train more junior labeling managers in their day-to-day activities

• Ability to run training and awareness sessions on labeling processes and ability to clearly articulate expectations of the labeling process to stakeholders.

• Takes appropriate risks to advance new concepts and methodologies that are moderately complex, participating in pilots as directed and other continuous improvement projects.

• 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.

• Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.