Regulatory Operations Documentation Specialist (Contractor)

Shionogi • Florham Park, NJ

5h • $40 - $57

About The Position

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 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. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits 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. 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, long-term incentive, 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 [email protected].

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.

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.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED