Artwork Implementation Manager
- Contract
- Labelling & Artwork
- United Kingdom
Proclinical is seeking an Artwork Implementation Manager to ensure the timely approval and implementation of packaging components in compliance with European Medicines Agency guidelines. This role involves coordinating across various business lines to meet regulatory timelines for artwork changes and responding to documentation requests related to labelling.
Responsibilities:
- Coordinate with European Country Offices on regulatory activities for packaging artwork labelling.
- Communicate with stakeholders to document labelling artwork timelines.
- Collaborate with Research Strategists and Manufacturing to meet artwork completion targets.
- Initiate and manage packaging artwork change controls using the ePALMS system.
- Support affiliates with electronic Artwork Requests (PARS) and ensure accurate data entry.
- Track and monitor the status of PARs and approvals, communicating updates as needed.
- Evaluate labelling updates and address issues with relevant leads and strategists.
- Develop relationships with stakeholders in WSR and PGS.
- Assist in creating accurate artwork change control instructions.
- Identify and route artwork to appropriate approvers using ePALMS.
- Follow up with Market Approvers and address regulatory queries during the approval process.
- Work independently with minimal supervision and accommodate remote work requirements.
- Travel within the EU if necessary
Key Skills and Requirements:
- Experience with regulated document management tools for labelling artwork.
- Proficiency in PC skills, including spreadsheets and database management.
- Strong interpersonal, writing, and verbal communication skills.
- Experience in quality environments with a focus on accuracy.
- Familiarity with electronic Artwork and Labelling Management Systems.
- Excellent organizational skills and ability to manage multiple projects.
- Demonstrated project management experience.
- Knowledge of manufacturing processes, preferably in pharmaceuticals.
- Capacity to make informed business decisions in uncertain situations.
If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at c.siljeur@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.