Senior Manager, Labelling Strategy and Development

GSK•Upper Providence Township, PA

10d•Hybrid

About The Position

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.

Requirements

Bachelor’s Degree in Life Sciences related discipline
8 plus years' experience in pharmaceutical regulatory affairs
4 plus years in a labelling-focused role in a matrixed environment
Experience authoring or contributing to core US labelling documents (e.g. USPI, patient information)
Experience with cross-functional labeling reviews involving Regulatory, Medical Affairs, Safety/Pharmacovigilance, Legal, CMC and Commercial teams

Nice To Haves

MS, PharmD, PhD
Developed interpersonal, presentation and communication skills
Influences effectively in a matrix environment
Recognizes key issues which require escalation
Runs efficient meetings
Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully

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 labelling responsibilities.
Authors healthcare professional and patient information for assigned products for the US market and ensures compliance with US Local Labelling processes including submission of Country Labelling Differences.
Develops high quality USPI and associated strategy for EP products by providing local regulatory advice and expertise regarding US prescribing and patient information requirements, precedents, and competitor labelling.
Authors responses to labelling questions from the FDA.
Ensures effective communication within Labelling Strategy and Governance, and with other GSK labelling groups (e.g., Global Labelling Operations and Regulatory Therapeutic Group) regarding issues which may impact other GSK products
Makes well thought out, efficient decisions, with some guidance from Line Manager, based on pertinent facts, relevant information, risk assessment and good judgment with respect to the compliance of healthcare professional and patient information with reference to GSK internal standards, and US regulatory requirements.
Works flexibly but within the limitations of internal and external requirements to facilitate risk mitigation within project teams, such as anticipating regulators’ questions regarding data, format, or content
Demonstrates knowledge of relevant US regulations and guidances, and adapts to changes in regulatory requirements and internal standards as required
In conjunction with the GRA Regional Director, represents GSK at label meetings with FDA.