RemoteFull timeMid levelPosted today
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Pay 55-60/h depending on experience
- Submission readiness, publishing, validation, QC review, document formatting, template creation, and hyperlinking (45%)
- Archiving/closeout of submission sequences (20%)
- Archives HA correspondence (including emails, letters, faxes, contact reports and OPDP submissions) in US archive and EDMS (15%)
- Supports document retrieval as requested (electronic and paper); Supports inspections re: document requests as needed (5%)
- Creation and maintenance of SPL for Drug Establishment, Drug Listing, PI (according to HL7 standards) (5%)
- Delivery of metrics and reporting compliance (5%)
- Support development and implementation of global IT tools (Smartsheet, Veeva, eCTD 4) (5%)
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