Regulatory Operations Contractor

Shionogi Inc.•Florham Park, NJ

About The Position

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 contractor will also be responsible for the archiving of Health Authority (HA) correspondences for various products, including to and from the HA, and the archiving of submissions and correspondences from applications acquired by Shionogi, which includes information from Tanabe, Akros, and Apnimed.

Requirements

High school degree required
Knowledge of Acrobat Adobe
Knowledge of Veeva RIM

Nice To Haves

Pharmaceutical industry experience is a plus, but not required.

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 Regulatory Operations team