Medpace
Regulatory submissions-Start Up & Contract Specialist (dual role)
This job is now closed
Job Description
- Req#: 10956
Employer Industry: Clinical Research Organization
Why consider this job opportunity:
- Competitive compensation and benefits package
- Flexible work environment
- Structured career paths with opportunities for professional growth
- Competitive PTO packages
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
What to Expect (Job Responsibilities):
- Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Georgia
- Prepare and submit responses to queries and amendments to clinical trial applications
- Ensure submissions comply with applicable regulations and guidance documents
- Draft, review, negotiate, and finalize agreements and other legal documents required for clinical studies
- Coordinate with internal functional departments to ensure site startup activities align with contractual processes
What is Required (Qualifications):
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field or Law)
- Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies
- Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site
- Knowledge of local regulatory guidelines and legislation
- Fluency in Georgian and English
How to Stand Out (Preferred Qualifications):
- Excellent organizational and prioritization skills
- Proactive approach and ability to work independently
- Knowledge of Microsoft Office
- Great attention to detail and excellent oral and written communication skills
#ClinicalResearch #RegulatorySubmissions #CareerGrowth #FlexibleWork #CRO
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Medpace Holdings, Inc. is a midsize, clinical contract research organization based in Cincinnati, Ohio.
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