Regulatory Operations Documentation Specialist

Overview

This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission.  The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.

Responsibilities

Below is a list of the main activities needed to fulfill the requirements of the role. It is not meant to be a comprehensive list, but rather, provide an overview of the specialized skills and expertise required:

• Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
• Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
• Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
• Assist the archiving and retrieval of documents from offsite storage facilities.
• Provide ongoing support to the Regulatory Operations team.

Minimum Job Requirements

• High school degree required; Associate’s degree preferred.
• Pharmaceutical industry experience is a plus, but not required.
• 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.

Additional Information

The hourly rate for this position is $40 - $57. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, applicable allowances, or any additional compensation that may be associated with this role. 

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), 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 for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.

Japanese pharma company specializing in infectious disease and pain treatments with strong R&D focus. Headquartered in Osaka, Japan.

shionogi.com