Artwork and Packaging Project Manager
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.
- 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.