Resident Ectd Wrangler
Current- Compilation of electronic submissions for pharmaceutical marketing authorizations (eCTD, NeeS).- Technical management of pharmaceutical product dossiers.- Creation and management of pharmaceutical documentation templates (CMC, study reports etc.).- Performance of document authoring trainings.- Installation, validation and administration of pharmaceutical information systems.- Authoring of standard operating procedures, technical training documentation and user manuals.- Technical user support for regulatory affairs staff.