Regulatory Operations Documentation Specialist (Contractor)

Qpex Biopharma • Florham Park, NJ

9h • $40 - $57

About The Position

Overview The Regulatory Operations Document Specialist Contractor will focus on formatting documents based on Shionogi standards and support remediation efforts by bookmarking, hyperlinking, and performing quality control measures to ensure our work product is compliant with our electronic submissions. In addition, this assignment will focus on providing general assistance to the Regulatory Affairs team as a whole whilst focusing on supporting Regulatory Operations. Detailed Description Assist in performing document formatting per Shionogi standards for submission related documentation. Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files. Provide support to the Regulatory Operations team. Provide general assistance to the Regulatory Affairs department as needed.

Requirements

• High school degree required; Associate degree preferred.
• 2 years minimum experience in regulatory affairs within a pharmaceutical or biotechnology company.
• Proficient in MS Office and Acrobat Adobe.
• Experience with ISI Toolbox or equivalent software packages.
• Experience with database systems; Veeva is a plus.
• 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.
• You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits

Responsibilities

• Assist in performing document formatting per Shionogi standards for submission related documentation.
• Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files.
• Provide support to the Regulatory Operations team.
• Provide general assistance to the Regulatory Affairs department as needed.

What This Job Offers

• Education Level: High school or GED