Regulatory Operations Contractor

The temporary contractor will assist the Regulatory Operations team with:

• The preparation of submission-related tasks for various products. This assignment involves supporting the preparation, remediation, and quality control (QC) of documentation for submissions to Health Authorities.
• The archiving of Health Authority (HA) correspondences for various products This includes to and from the HA.
• The archiving of submissions and correspondences from applications acquired by Shionogi. This includes information from Tanabe, Akros, and Apnimed.

• Assist in the conversion of tables, figures and listings from txt to pdf
• Assist in the downloading and QC of information from one location to another
• Assist in the preliminary QC of pdf bookmarks and hyperlinks
• Assist in the preliminary creation of pdf bookmarks in documents to ensure submission readiness
• Assist in the compilation of pdf documents to create a single submission ready document
• Assist in verifying documents in a published outline
• Assist in verifying metadata on a published sequence
• Assist in archiving submission sequences and correspondences in Veeva RIM
• Provide support to the Regulatory Operations team

MINIMUM QUALIFICATIONS TO THE JOB ASSIGNMENT SCOPE

• Education: High school degree required
• Experience: Pharmaceutical industry experience is a plus, but not required.
• Competencies & capabilities: Knowledge of Acrobat Adobe, Veeva RIM
• Certifications, if applicable: N/A

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. 

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.