EU Labelling Manager

Key People

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Job ID :

14852


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Cambridge,Cambridge,


Key Skills :

European Labeling Manager


Salary :

£45.00 - £53.00 per hour


Date Posted :

30 Apr, 2019



Company Name :

Key People


Location1 :

Cambridge




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

European Labelling Manager

Key Responsibilities:
The Labeling Process Management Manager, reporting into the Director Labeling Process Management, will be responsible for:
* Labeling aspects supporting timely Amgen 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.
* Overseeing cross functional labeling project teams and ability to execute consistent product labels in 49 countries in Europe.
* The creation of artwork components for all of Europe to make sure of timely launch of products.
* Creation of Patient Information Leaflets (PIL) in central Europe to ensure Patients can safely and effectively use Amgen products.
* Applying European Labeling regulations, guidelines and industry standards and be able to apply this knowledge to ensure fantastic E2E labeling processes at Amgen.
* Leading particular labeling initiatives and execute deliverables 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 high level 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 in accordance with regulations and company guidelines
* Develop Patient leaflet content using knowledge gained from previous exposure to health authority and patients and execute it through regulatory approval to make sure of safe and efficient use of Amgen products
* Accountable for successful Readability Testing: establish and execute process to successful results, (Review EU label, patient leaflet, packaging components, instructions for use (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 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 Amgen 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
* Using project management skills initiate and manage translations for EU-central countries ensuring health authority timelines are met.
* Project manage timeline waivers and approve in LEXA. Triage and review deviation requests for appropriateness and completeness.
* Review and approve MAA EN master artwork to ensure compliance with approved mock up/text mapping
* Negotiate and address questions with EMA on specimens submitted prior to launch.
* Reportability of label changes to HA
* Mentoring/training junior team members and local regulatory, operations staff on End to End Labeling processes & systems as requested by supervisor.

If this role may be of interest, please get in touch with Ross Wilson at rwilson@keypeople.co.uk or on +44(0)1727 817621


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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