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Clinical Associate Submissions – Regulatory, Grade 140, M.W.D - IQVIA Biotech

IQVIA · Frankfurt Am Main, Hesse, DE

Clinical Associate Submissions – Regulatory Homebased Germany IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support cli...

Job description

Clinical Associate Submissions – Regulatory Homebased: Germany: IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster. Job Overview: Position requires EU CTR experience for Germany and Austria, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions: As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary. You will also ensure adherence to standard...