Senior Manager, Labelling Strategy and Development

Job Purpose:

Accountable to drive and deliver US Product Information (PI) (including healthcare professional and patient information) for Established Products (EP) in compliance with internal and external standards, processes and policies. Interface directly with all GSK functional experts who contribute data for US Prescribing Information and ensure compliance with GSK Regulatory Submission processes. The role may include some global labelling responsibilities.

This is a hybrid role based at our Upper Providence site in Collegeville, PA requiring 2-3 days on-site per week average.

Key Responsibilities:

The role is accountable for authoring and maintaining USPI for a portfolio of Established Products (EP), in conjunction with functional experts, and for authoring US patient information. The incumbent may also generate responses to FDA questions related to US prescriber and patient information. 

The role may include some global label...