Regulatory Operations Documentation Specialist – Contractor
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Job Description
Regulatory Operations Documentation Specialist Contractor supporting document formatting and compliance for submissions in the pharmaceutical industry. Assisting the Regulatory Affairs team with quality assurance and operations.
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.
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.
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