Global Labelling Systems

2 weeks ago

London, Greater London, United Kingdom Novartis Full time

Summary:

About the Role:

Major accountabilities:

  • 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 endusers 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 FDAapproved 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.

Your Experience:

  • 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.

Commitment to Diversity & Inclusion:


Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


Join our Novartis Network:

Division

Development

Business Unit

Pharmaceuticals

Location

United Kingdom

Site

London (The Westworks)

Company / Legal Entity

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No


Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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