The Role:The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role as part of the process for coordination, development and implementation of new...
To support workload in one or more ALIM regional leads and will be responsible for verification of information in final printed secondary packaging component artwork against Editor's copy documents for accuracy and consistency. Involves technical review of secondary packaging components across portfolio's and across multiple markets worldwide according to specifications and trade dress requirements as outlined in SOPs.
- Provide document verification proofing of packaging and labeling artwork versus Editor's Copies (EC's) to assure compliance with required local country (and/or regional) format and style guidelines.
- Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines.
- Initiate discussions with ALIM Market Coordinators, WSR PCOs or PGS artwork centers/plants when inconsistencies are discovered.
- Annotate packaging and labeling artwork using digital tools.
- Use appropriate judgment and approve or reject packaging and labeling artwork.
- Provide clear explanation to PGM artwork center for accurate re-creation of artwork when needed.
- Monitor individual document verification proofing workload and ensure ALIM meets agreed upon Artwork Request (PAR) timelines.
- Provide editorial comments for regulatory documents prior to creation of artwork by PGM sites to GLMs and/or WRS if requested.
- Escalate issues and initiate discussions with ALIM Market Coordinators (or GLM Hub Labeling Managers, WRS PCOs etc.) to drive consistency within and across labeling documents.
- Bachelor's degree in Life Sciences plus 2 years' experience* in proofing pharmaceutical labeling, packaging components or medical/scientific documents. (4 plus years' experience in pharmaceutical proofreading may be considered in lieu of degree.)
- Strong editing/proofreading skills, including broad vocabulary and knowledge of medical/scientific terminology.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me:
or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.