A Manager of Global Labeling Manager in Irvine CA, is available through Adecco Medical and Science. **Candidate Must Have Experience with the Following*** Must have experience with Facilitating Core Labeling Review Committee and US Labeling Review Committee meetings for assigned marketed or development product. You must ensure the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes and follow-up of action items to complete resolution. You will provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets, FDA regulations, and FDA guidance. Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
Global Label Manager job responsibilities include:
Facilitating Core Labeling Review Committee
Ensure the timely distribution of preparatory documentation
Identification of issues for discussion
Provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets
Must have experience with FDA regulations and guidance
Bachelor's degree in a related scientific discipline or Masters, PharmD or PhD with minimum of 2 years' experience.
Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
4 years related experience within a pharmaceutical company, CRO or similar organization Insert customer requirements
Detail-oriented, well organized and good planning skills.
Ability to manage multiple projects and deadlines.
If you are interested in this Global Label Manager job in Irvine, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position, please contact Hari Dhurjaty at 585-613-3037or firstname.lastname@example.org
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