CYTOKINETICS, INC – $79,706.00/Year

Must have at least 1 year of prior work experience in each of the followingbr 1. Preparing highquality electronic regulatory dossiers including eCTDs according to health authority requirements and guidance, including publishing, submission, and lifecycle management of dossiers.br 2. Preparing nonroutine to complex submissions for INDs and NDAs using docuBridge and at least one of the following associated publishing tools DXCToolbox, eCTD Viewer, andor Lorenz eValidator.br 3. Formatting PDFs using DXCToolbox to comply with FDA and other health authority specifications.br 4. Performing quality control checks including data verification against source documents and performing quality control checks on published outputs of submissions prior to dispatch to the FDA.br 5. Reviewing content for proper abbreviations, cross references, and literature citations.br 6. Archiving paper and electronic submissions.br 7. Experience with FDA, HC, EU, and ICH guidelines related to regulatory submissions, clinical trials, and marketing applications.