Regulatory Affairs Specialist/Officer
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- and site-level essential documents required for site activation. The documents required for each study site and country are documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the Regulatory Affairs Specialist reviews all required essential regulatory documentation for completeness, accuracy and quality, ensuring that documentation meets applicable regulatory and study requirements and supports timely site activation. Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted. Tracks EDP review details in the applicable data tracking system. Education and Experience
Requirements:
Good English language (written and oral) communication skills as well as local language whereapplicable Good attention to detail and quality as well as editorial/proofreading skills Good interpersonal skills to work effectively in a team environment Good computer skills including the use of Microsoft Word, Excel, Power Point; Basic organizational, time management, and planning skills to create and follow timelines, conductlong-range planning, adapt to changing priorities and handle multiple projects Good negotiation skills Capable of working independently with direction and exercising independent judgment Bachelor's degree/previous experience comparable to 2+ years Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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