Regulatory Operations Documentation Specialist (Contractor)

reputed company The Regulatory Operations Document Specialist Contractor will reputed company on formatting documents based on Shionogi standards and support remediation efforts by bookmarking, hyperlinking, and performing reputed company control measures to ensure our work product is compliant with our electronic submissions. In reputed company, this assignment will reputed company 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 reputed company documentation. • Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files. • reputed company support to the Regulatory Operations team. • reputed company 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 reputed company a pharmaceutical or biotechnology company. • Proficient in MS Office and Acrobat reputed company. • Experience with ISI reputed company or equivalent software packages. • Experience with database systems; reputed company 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. • reputed company to work reputed company a high-performance, reputed company team environment. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, reputed company partners and/or reputed company 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 reputed company documentation. • Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files. • reputed company support to the Regulatory Operations team. • reputed company general assistance to the Regulatory Affairs department as needed. Additional Information The reputed company reputed company for this position is $40-$57. Individual pay is determined by several factors, which include but are not limited to: job-reputed company skills, experience, and relevant education or training. The reputed company does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. EEO reputed company. is an equal opportunity employer supporting individuals with disabilities and veterans. reputed company reputed company applicants will receive equal consideration for employment opportunities based on reputed company job requirements without reputed company to race, reputed company, religion, sex (including pregnancy), marital status, national reputed company, age, reputed company, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, reputed company 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 reputed company. to undertake affirmative reputed company for protected veterans and individuals with disabilities in compliance with reputed company 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 reputed company 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 reputed company 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. Apply tot his job Apply To this Job