Hiring Safety and Regulatory Quality Control in NYC, NY @Direct client.

Hiring Safety and Regulatory Quality Control in NYC, NY @Direct client.

02 Mar 2021
New York, New york city, 10017 New york city USA

Hiring Safety and Regulatory Quality Control in NYC, NY @Direct client.

Quality document control, comparison of artwork versus editor's copy and supporting documentation.

Supports 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 client portfolio and across multiple markets (languages) worldwide according to specifications and trade dress requirements as outlined in client SOPs.

Liaises with Worldwide Safety & Regulatory (WSR) client Country Offices (PCOs), Global Labeling Management (GLM), the geographically distributed artwork centers within client Global Supply (PGS).

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 client 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 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. Attention to detail and ability to focus attention for long periods of time. Robust text comprehension and ability to identify and mark errors in typography, spelling, word usage, style, punctuation and grammar. Ability to apply these skills across multiple languages, especially non-native language is highly desirable. Ability to use mechanized and electronic proofreading tools such as vision systems and comparators. Excellent interpersonal, organization and communication skills. Individual must be flexible and capable of prioritizing projects, meeting deadlines and working well under pressure.

Must be able to work effectively with frequent reading, which may cause eye strain. 20/20 color vision (corrected) is required. Thanks!

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    Infobahn Softworld Inc.
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