Packaging Artwork Change Project Manager

DUTIES AND RESPONSIBILITIES:

- Liaise with clients' European Country Offices in coordinating regulatory, new, or updated 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 according to agreed timelines and established procedures.
- Support Affiliates with initiation of electronic Artwork Requests, ensure accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval.
- Track/monitor the status of Artwork Requests and artwork component approvals with the Affiliates.
- Communicate with Affiliates and Manufacturing on status of Artwork Requests to ensure agreed regulatory timelines are met.
- Evaluate content of labeling updates and raise issues with the EU Lead and the Regulatory Strategists as appropriate.
- Develop and maintain relationships with relevant stakeholders.
- Use pharmaceutical packagingstorage, retrieval, life cycle management, and tracking of labeling artwork for packaging components in a business enterprise system.
- Bachelors degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).
- Must be familiar with regulatory environment, and have an understanding of labeling regulations and controls.
- Must be able to interact with clients globally.
- PC skills including spreadsheet and database management are required.
- Diplomatic with strong interpersonal, writing, and verbal communication skills required.
- Experience 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.
- Excellent organizational skills.
- Ability to handle a number of product artwork changes at the same time, with differing stakeholder groups.
- Strong demonstrated project management experience and expertise.
- 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.