Proclinical is advertising a vacancy for an Artwork Implementation Manager with one of the most renowned pharmaceutical companies in the world. This prestigious organisation, which specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology, is seeking an experienced incumbent to join their Kent-based team on a contract basis.
The Artwork Implementation Manager (ALIM MC) is responsible for initiating and building the Artwork Requests (Ars) in collaboration with local markets (PCOs), assuring all required information, specifications, and/or supportive documentation is available for plants/AWCs to execute the production of product Labelling related packaging components. Furthermore, they will negotiate Artwork Change Control logistics across multiple company departments (as well as multiple markets) to assure Regulatory timelines for Implementation are met and that product supply is not met.
The ALIM MC will also track Artwork, Key Performance Indicators (KPIs), such as volume and timelines, for assigned projects. They will be accountable for Final Label Content rests with the PCOs or functions.
Job Responsibilities:
- Liaising with markets and stakeholders to gather all necessary information to initiate and build PARs (according to local or regional requirements) to enable plant production of Labelling Artwork with minimal rework and to meet Implementation requirements.
- Creating Editors Copy (EC) for select markets depending on language(s) involved and specific custom services negotiated with markets in line with SOPs.
- Liaising with GRO GLM/ILG functions, GRA/PCOs and PGS AWCs, or Demand Management lines to coordinate any unique factors that need to be considered. This may include documents agreement on Artwork timelines across stakeholders, escalating any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary.
- Acting as the ePALMS Market Coordinator.
- Evaluating content of Labelling updates and raising potential issues with GRA, PGS, or relevant local markets as appropriate to minimise impact on schedules.
- Evaluating PGS sites impacted by Labelling updates.
- Initiating PARs in collaboration with assigned markets, ensuring attributes (system metadata) are correct, ensuring all relevant Regulatory documents are included and routed for any shared packs, and assuring that agreed upon content is received in appropriate formats, and is either reflected in a combined EC or as a separate EC for each market according to regional agreements and relevant job aids.
- Using Biopharmaceutical Packaging & Artwork knowledge in combination with Trade Dress Style Guides, Country Specific Requirements, and/or other appropriate guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs; escalating issues or concerns if/as needed.
- Reviewing proofreading reports and resolving any technical formatting questions or errors; assuring necessary proofreading of final printed Artwork against EC is completed using appropriate tools.
- Initiating, managing, and tracking any necessary rework.
- Monitoring progress and following up as needed with appropriate PGS AWCs or GRA PCOs to assure agreed timelines are met and any Regulatory content issues that arise during the approval process are addressed.
- Tracking and communicating final approved Labelling to list off relevant departments and stakeholders as required following final market review and signoff.
- Uploading any locally reconditioned or repackaged Artworks into ePALMS using dual role system capabilities to assure correct Artworks are available for the next revision cycle.
Skills and Requirements:
- A Bachelors' degree in an appropriate discipline.
- 4-8 years of related work experience, with at least 2 of those years in a Labelling Artwork Change Control & Implementation capacity; alternatively, positions in Regulatory Strategy, Demand Management, Quality Operations, or Supply Chain capacities with frequent interaction with ALIM and Artwork Change Control & Implementation will be considered.
- Familiarity with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging, and distribution processes, as well as a basic understanding of Artwork & Labelling regulations and controls.
- An in-depth knowledge of PGS manufacturing and site processes/requirements.
- Must be able to collaborate with cross-functional teams, negotiating across globally distributed affiliates and manufacturing site personnel, and communicating across multiple levels of the organisation in a clear, professional manner.
- Demonstrable strong PC business software skills, including document authoring, spreadsheet, database management, and presentation applications.
- Proficiency in English, with any additional languages a highly desired attribute.
- An ability to work under tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts, and escalate if/as needed.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 0203 871 8093 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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