Regulatory Operations Contractor

Job description

Overview The temporary contractor will assist the Regulatory Operations team with: - The preparation of submission-related tasks for various products. This assignment involves supporting the preparation, remediation, and quality control (QC) of documentation for submissions to Health Authorities. - The archiving of Health Authority (HA) correspondences for various products This includes to and from the HA. - The archiving of submissions and correspondences from applications acquired by Shionogi. This includes information from Tanabe, Akros, and Apnimed. Responsibilities: - Assist in the conversion of tables, figures and listings from txt to pdf - Assist in the downloading and QC of information from one location to another - Assist in the preliminary QC of pdf bookmarks and hyperlinks - Assist in the preliminary creation of pdf bookmarks in documents to ensure submission readiness - Assist in the compilation of pdf documents to create a single submission ready document - Assist in verifying documents in a published outline - Assist in verifying metadata on a published sequence - Assist in archiving submission sequences and correspondences in Veeva RIM - Provide support to the Regula...