Regulatory Operations Document Specialist Contractor

Overview

The Regulatory Operations Document Specialist Contractor will focus on formatting documents based on Shionogi standards and support remediation efforts by bookmarking, hyperlinking, and performing quality control measures to ensure our work product is compliant with our electronic submissions. In addition this assignment will focus on providing general assistance to the Regulatory Affairs team as a whole whilst focusing on supporting Regulatory 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.

Minimum 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.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.