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Shionogi Inc. (U.S.) logo
Shionogi Inc. (U.S.)

Our mission is to supply the best possible medicines to protect the health and well-being of the patients we serve

Regulatory Operations Documentation Specialist – Contractor

ComplianceComplianceOtherRemoteMid LevelTeam 501-1,000Since 2001H1B No SponsorCompany SiteLinkedIn

Location

New Jersey

Posted

118 days ago

Salary

$40 - $57 / hour

Seniority

Mid Level

High School2 yrs expEnglish

Job Description

Regulatory Operations Documentation Specialist – Contractor

Shionogi Inc. (U.S.)

• 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.

Job 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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