Shionogi

About Shionogi

The Regulatory Documentation Specialist is responsible for supporting the Regulatory Affairs Submission Team with the preparation of regulatory documents for both eCTD (electronic common technical document), as well as traditional paper submissions. The scope of this role includes assisting in the document remediation and formatting of documentation for submissions to Health Authorities. The ideal candidate for this entry level position is enthusiastic, highly organized and flexible. DUTIES AND RESPONSIBILITIES Perform document formatting for both paper and eCTD submissions. Assist in the bookmarking, hyperlinking and quality control checking of electronic files for eCTD submissions. Provide support to the Regulatory Submissions Team. Filing and organizing of Regulatory Documentation. Provide general assistance to the Regulatory Affairs department as needed. MINIMUM JOB REQUIREMENTS High school degree required; Bachelor’s degree preferred. Pharmaceutical industry experience is a plus, but not required. Demonstrated proficiency with computer systems, Adobe Acrobat Pro and Microsoft Office Suite. 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. Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. 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.

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Company Info

Legal Form: GmbH

Company Type: Subsidiary or Business Segment

Company Size: 51 - 250

Revenue: 100 - 500 million (USD)

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Hiring Locations: 11

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