Artwork Implementation Manager
A well-known international pharmaceutical company with sites around the globe is looking to fill an Artwork Implementation Manager position. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. ProClinical is advertising this vacancy to connect a hard-working individual with the company's UK team based in Dover. This is a contracted position.
The Artwork Implementation Manager will be responsible for initiating the Packaging Artwork Requests (PARs) and will coordinate across business lines to assure key regulatory timelines for Artwork Implementations are met. Following this, the Artwork Implementation Manager will then track the approval status of packaging artwork components across the EU region. The incumbent will then track the approval status of packaging artwork components across the EU region.
- Liaising with European Country Offices in coordinating Regulatory activity for packaging artwork labelling for Client products.
- Communicating/coordinating with key stakeholder groups for documentation of labelling artwork timelines.
- Liaising 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).
- Raising and coordinating packaging artwork change controls in the Artwork system (ePALMS), according to agreed timelines and established procedures.
- Supporting Affiliates with initiation of electronic Artwork Requests (PARs), ensuring accurate entry of required data, and ensuring that all relevant regulatory documents are attached and routed for approval.
- Using ePALMS to track/monitor the status of PARs and artwork component approvals with the Affiliates.
- Communicating with Country Offices and Manufacturing on status of PARs to ensure agreed regulatory timelines are met.
- Evaluating the content of labelling updates and raising issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.
- Developing and maintain relationships with relevant stakeholders in WSR and PGS.
- Using pharmaceutical packaging and artwork knowledge and experience to collaborate with Manufacturing Artwork Centres to assist Country Offices in creating Artwork change control instructs - also known as Editors Copies (EC).
- Identifying appropriate artwork Country Approvers and electronically route artwork to them for approval using the ePALMS system.
- Interacting and following up with all Market Approvers as needed and redirecting and Regulatory queries as they arise during the approval process.
- Working with minimal direct supervision, and occasionally from home.
- EU travel if/as requested.
Skills and Requirements:
- A bachelor's degree or equivalent in an appropriate discipline.
- Between 2-4 years of related work experience.
- Extensive experience of working with regulated document management tools supporting storage, retrieval, lifecycle management and tracking of labelling artwork for packaging components in a business enterprise system, e.g. ePALMS or similar.
- Demonstrable familiarity with the Regulatory environment, and an understanding of labelling regulations and controls.
- An ability to interact with globally distributed Stakeholders and Clients across country offices, manufacturing sites and Artwork Centre personnel in a professional manner.
- PC skills, including spreadsheet and database management are required.
- Diplomatic with strong interpersonal, writing and verbal communication skills.
- Experience of working in a quality environment, strictly following SOP and working practices, and focusing on accuracy, and a right first-time approach to their work.
- Demonstrable experience of electronic Artwork and Labelling Management Systems, e.g., Client ePALMS business systems, or equivalent.
- Excellent organisational skills, with a strong focus on handling multiple artwork projects and changes at the same time.
- Demonstrated project management experience and expertise.
- In depth knowledge of manufacturing processes and requirements, with a preference for a knowledge of Pharmaceutical manufacturing preferred.
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 Sudsosk on +44 203 871 8093upload 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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