Regulatory Operations Documentation Specialist

Shionogi Inc.•Florham Park, NJ

About The Position

This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.

Requirements

High school degree required
Proficient in MS Office and Acrobat Adobe.
Experience with ISI Toolbox or equivalent software packages.
High level of attention to detail and accuracy in work.
Effective time management and organizational skills.
Strong written and verbal communication skills.
Able to work within a high-performance, collaborative team environment.

Nice To Haves

Associate’s degree preferred.
Pharmaceutical industry experience is a plus, but not required.
Experience with database systems; Veeva is a plus.

Responsibilities

Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
Assist the archiving and retrieval of documents from offsite storage facilities.
Provide ongoing support to the Regulatory Operations team.