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First Name*

Last Name*

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Job type: Permanent

Discipline: Labelling & Artwork

Location: United Kingdom

A lifetime opportunity has arisen for Artwork and Packaging Project Manager to join a Healthcare organisation and lead timelines to assure Artwork implementation are met. This is a contracted, homebased role. The Contractor is responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines.

Job Responsibilities

Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labelling for Client products.
Communicate/co-ordinate with key stakeholder groups for documentation of labelling artwork timelines
Liaise with Research Strategists on target dates for artwork completion on behalf of the Country Offices, and in conjunction with Manufacturing (working to SOPs/best practice guidelines).
Raise and coordinate packaging artwork change controls in the Artwork system (ePALMS) according to agreed timelines and established procedures, by performing the following activities:
Support Affiliates with initiation of electronic Artwork Requests (PARS), ensure accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval.
In a timely manner, communicate with Country Offices and Manufacturing on status of PARs to ensure agreed regulatory timelines are met.
Evaluate content of labelling updates and raise issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.
Develop and maintain relationships with relevant stakeholders in WSR and PGS.
Use pharmaceutical packaging & artwork knowledge and experience to collaborate with Manufacturing's Artwork Centres to assist Country Offices in creating accurate Artwork change control instructions - so called 'Editors Copies' (EC).
Interact and follow up with all Market Approvers as needed, and re-direct any Regulatory queries as they arise during the approval process.
Work with minimal direct supervision. Working from home at times is a required at times.

Skills and Requirements

Extensive experience of working with regulated document management tools supporting; storage, retrieval, lifecycle management and tracking of labeling artwork for packaging components in a business enterprise system (e.g. ePALMS or similar).
Must be familiar with Regulatory environment and understand labelling regulations and controls.
Must be able to interact with Client's globally distributed Stakeholders:
Country offices, Manufacturing sites and Artwork Centre personnel in a professional manner.
Strong, demonstrated project management experience and expertise 10. In depth knowledge of manufacturing and manufacturing Plant processes/requirements. Knowledge of Pharmaceuticals manufacturing preferred.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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