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European Labelling Manager

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
United Kingdom
Region:
Cambridgeshire
Contract Type:
Temp / Locum / Contract
Currency:
£
Salary:
45 to 52 per hour
Posted:
23-Sep-19
Recruiter:
Key People
Job Ref:
#24583

My client, a large pharmaceutical company in the Cambridge area, is looking for a European Labelling Manager on a 12 month contract paying up £52.

The Labeling Process Managemnt Manager, reporting into the Director Labeling Process Management, will be accountable for:

* Labeling aspects to support timely company product launches. The Manager achieves this by understanding the EU regional business goals and how to achieve those goal by creating and sustaining the most competitive product labels within European regulations and guidelines.
* Leading cross functional labeling project teams and ability to execute error free product labels in 49 countries in Europe.
* The creation of artwork components for all of Europe to enable product launch.
* The creation for Patient Information Leaflets (PIL) in central Europe to ensure Patients can safely and effectively use company products.
* Applying European Labeling regulations, guidelines and industry standards and be able to apply this knowledge to ensure state of of the art E2E labeling processes at company.
* Leading specific labeling initiatives and execute deliverables by working with cross functional teams and leaders (includes continuous improvement projects to support the E2E labelling processes)
Principal responsibilities include, but are not restricted to:
* Apply expert labeling knowledge, industry experience and business needs to provide strategic input to stakeholders (Reg Affairs, Regional Ops, Artwork, Commercial) for the creation and execution of all labeling packaging components and launch plans e.g. health authority requirements, colour, layout, pack sizes, languages, branding.
* Develop EU package component labels according to regulations and company guidelines
* Develop Patient leaflet content using knowledge gained from previous interactions with health authority and patients and execute it through regulatory approval to ensure safe and effective use of company products
* Accountable for successful Readability Testing: establish and execute process to successful results, (Revise EU label, patient leaflet, packaging components, instructions for use (collectively referred to as PI), prepare protocol and share with vendor, request patient leaflet mock-up, attend pilot stage testing and amend protocol/leaflet as necessary for main stage. Review and finalise readability testing report and ensure submission ready.
* Accountable leading QRD compliance review of PI at all phases of health authority review and launch.
* Labeling contact person for internal and external audits
* Accountable for preparing responses to labeling questions from health authorities for EU-central markets, review comments, update PI & provide responses & updated mock ups
* Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions; escalate issues appropriately.
* Proactively identify opportunities or troubleshoot issues utilizing analytical skills to evaluate and interpret complex situations and problems using multiple sources of information with company systems & propose workarounds/corrective actions on LEXA, IMR, EPIC for all European countries. Provide daily support on above systems and TrackWise.
* Select and manage vendors for readability and linguistic reviews, including preparing responses to vendor queries

If the above may be of interest, please apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk


Closing Date:
21/10/2019

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