Job Description
Note: The job is a remote job and is open to candidates in USA. Shionogi Inc. is a pharmaceutical company, and they are seeking a Regulatory Operations Documentation Specialist Contractor. This role focuses on formatting documents according to Shionogi standards and supporting the Regulatory Affairs team with compliance efforts and general assistance.
- 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
- Skills
- High school degree required
- 2 years minimum experience in regulatory affairs within a pharmaceutical or biotechnology company
- Proficient in MS Office and Acrobat Adobe
- 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
- Associate degree preferred
- Experience with ISI Toolbox or equivalent software packages
- Experience with database systems; Veeva is a plus
- Company Overview
- Since 1878, we have been committed to developing new treatments to improve patients' lives worldwide. It was founded in 2001, and is headquartered in Florham Park, New Jersey, US, with a workforce of 501-1000 employees. Its website is http://www.shionogi.com.
- Company H1B Sponsorship
- Shionogi Inc. (U.S.) has a track record of offering H1B sponsorships, with 5 in 2025, 2 in 2024, 6 in 2023, 5 in 2022, 2 in 2021, 7 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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