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: Apply tot his job
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