- Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.
- Communicate/co-ordinate with key stakeholder groups for documentation of labeling 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.
- Using ePALMS track/monitor the status of PARs and artwork component approvals with the Affiliates.
- In a timely manner, communicate with Country Offices and Manufacturing on status of PARs to ensure agreed regulatory timelines are met.
- Evaluate content of labeling 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).
- Identify appropriate artwork Country Approvers and electronically route artwork to them for approval using the ePALMS system.
- 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.
- EU Travels if/as requested
Technical Skill 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).
Qualifications
- Must be familiar with Regulatory environment, and have an understanding of labeling 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.
- PC skills including spreadsheet, database management are required.
- Diplomatic with strong interpersonal, writing and verbal communication skills required.
- 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.
- Familiarity with, and demonstrated use of electronic Artwork and Labeling Management Systems (eg Client ePALMS business system) or equivalent.
- Excellent organizational skills. Must be able to handle a number of product artwork changes at the same time, with differing stakeholder groups.
- Strong, demonstrated project management experience and expertise 10. In depth knowledge of manufacturing and manufacturing Plant processes/requirements. Knowledge of Pharmaceuticals manufacturing preferred.
- Must have capacity to make appropriate business decisions when facing uncertainty.
- Must be a team player/builder. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
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Artwork Implementation Manager - Surrey, United Kingdom - Proclinical Staffing
Description
This role is responsible for initiation of Packaging Artwork Requests (PARS), and will coordinate across business lines to assure key regulatory timelines for Artwork implementation are met Following the initiation of the PAR process in the business system (ePALMS)
Primary Responsibilities
