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Regulatory Operations Documentation Specialist

Company

System One

Location

Florham Park, United States

Type

Full-time

Job Title: Regulatory Operations Documentation Specialist
Location: Florham Park, New Jersey
Type: 12-month Contract
Compensation: $31.00 – $54.00 per hour
Contractor Work Model: Remote
Hours: 40.0 hours per week


Overview
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.

Responsibilities


+ Support document formatting and QC in alignment with standards for submission-related materials.

+ Assist in the remediation and QC of PDF documents, i...

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