Global Labelling Systems & Project Lead

Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster.We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.Apply today and welcome to where we thrive together!The Role:The Global Labelling Systems and Project Lead position is responsible for leading activities related to global labelling systems and tools, including system compliance activities and emerging IT projects. This ill also include US Compliance activities related to Structured Product Labelling (SPL), product drug listing, and US Labelling regulations and guidance.This role offers hybrid working, requiring 3 days per week / 12 days per month in our White City, London office.

• As subject matter expert for existing global labelling systems, you will lead activities related to system upgrades and functional improvements.

• Lead global labelling system projects, partnering with IT business leads and other business stakeholders to continually improve current systems and processes to support global labelling activity.

• Support Country Organisations as the lead on Labelling system and process compliance related activities such as , deviation reporting, system training, and process compliance.

• Be a Super User and main business contact for HQ-Global Labelling and Country Organisation end-users for relevant labelling systems and processes, training materials, manuals and SOPs.

• Support and contribute to a compliance and quality culture for Global Labelling systems/processes and provide assistance during audits/inspections when required.

• Lead all aspects of Structured Product Labelling activities including managing external vendor, resolving FDA SPL questions and validation concerns, and listing and delisting product NDC.

• Be responsible for conducting independent and comprehensive reviews of US PI labelling documents to ensure regulatory labelling compliance with US 21 CFR 201 and FDA guidance applicable to US labelling.

• Partner with Regulatory Affairs (or Reg-CMC) managers and perform final quality checks, confirming that all FDA-approved labelling changes are accurately incorporated into internal master US product labelling documents prior to their being forwarded for use by other groups within Novartis e.g.: product packaging and US promotional materials/activities.

• Support proofreading activities of text for labelling of pharmaceutical products, ensure PLLR compliance within package insert and identify inconsistencies and errors, as needed.

• Prepare and review User Requirements Specifications and Functional Specifications, participate in formal system testing activities, as needed.

• Bachelor's degree with fluency in English as a business language required.

• Experience in the pharmaceutical industry, or equivalent relevant experience involving a good working knowledge of Regulatory Affairs, specifically labelling business processes and related tools.