Regulatory Operations Documentation Specialist – Contractor

Job 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.

Benefits: