Regulatory Artwork Implementation Specialist
2 weeks ago
ROLE SUMMARY
As a key member of the Artwork Management team, the Colleague will be responsible for coordinating the implementation of artwork and labeling across various markets and regions. This role requires a strong understanding of regulatory requirements and the ability to work closely with cross-functional teams to ensure compliance.
About the Role
- Initiate and manage artwork requests (PARs) in collaboration with local markets, ensuring all required information and specifications are available for production.
- Negotiate artwork change control logistics across multiple departments and markets to ensure regulatory timelines are met.
- Track artwork performance metrics, including volume, timelines, and quality, and hold accountability for final label content.
- Conduct research into root cause assessments for artwork quality investigations and identify opportunities for continuous improvement.
- Retrieve and generate reports in response to queries from regulatory agencies or legal teams.
Responsibilities
The Colleague will be expected to represent Artwork and Launch Implementation Management (ALIM) on cross-functional projects and lead ALIM continuous improvement teams. This may involve coordinating activities with other ALIM staff or external vendors.
- Liaise with markets and stakeholders to gather necessary information for PAR initiation and production.
- May create editor's copy for select markets, depending on language and negotiated services.
- Liaise with Global Regulatory Operations, Global Label Management, and other stakeholders to coordinate unique factors and document agreement on artwork timelines.
- Perform artwork system tasks according to agreed timelines and established procedures.
Requirements
- Evaluate labelling updates and raise potential issues with relevant teams to minimize impact on schedules.
- Evaluate PGS sites impacted by labelling updates.
- Initiate PARs with assigned markets, ensuring attributes and relevant documents are correct.
- Use Biopharmaceutical Packaging & Artwork knowledge to assure accurate packaging component ECs.
- Send PARs to relevant PGS sites and monitor aging PARs.
- Review proofreading reports and resolve technical formatting questions or errors.
- Initiate, manage, and track necessary rework.
- Identify market approvers for packaging artwork and electronically route for approval.
- Track and communicate final approved labelling to relevant departments and stakeholders.
About Pfizer
Pfizer is a patient-centric company guided by four values: courage, joy, equity, and excellence. We aim to create a trusting, flexible workplace culture that encourages employees to achieve work-life harmony and attracts talent.
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