Artwork and Packaging Project Manager

Highly Competitive
  1. Permanent
  2. Labelling & Artwork
  3. United Kingdom
London, England
Posting date: 30 Oct 2020
33861

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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