Pharmacovigilance Project Manager I, IT |
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Counsel - Trademarks |
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PQA Engineer II |
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Voice Network Engineer |
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Legal Assistant |
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Verification Engineer |
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Executive Assistant to IT and Transition |
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Manufacturing Engineer III |
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Product Director |
| AmerisourceBergen (NYSE:ABC) is one of the world's largest pharmaceutical services companies ... |
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Publisher
| Details |
Country: USA
Location: Illinois-Chicago North Abbott Park
Total applied: 38 |
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Publisher
Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Work with US and/or ex-US Global Regulatory Affairs Project Teams in the creation of compliant regulatory submissions.These submissions are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency. This individual will perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Position will also expedite, manage, and coordinate activities for a Global Project Team in the development of published submissions within required timelines and represent Regulatory Operations Publishing on Global Project Teams or Submission teams as necessary. Additional responsibilities include the organization, draft and/or editing of internal processes and standards documents relating to publishing and publishing deliverables, assist in the testing and validation of software updates or enhancements, trancing metrics associated with submission publishing and rework.QualificationsBachelor's degree preferred but willing to look at relevant experience in lieu of this requirement.Candidate should have at least 2-3 years of experience in regulatory affairs publishing that includes the creation of reports and/or regulatory submissions. Must be competent using publishing-related software tools including CoreDossier, Adobe Acrobat, and MS Word, etc. Experience in ISI eCTDXpress, or other eCTD publishing tools, desirable. Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.
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