Clinical Trial Regulatory Advisor

🔥 38 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide regulatory and technical support for assigned regulatory work • Review and finalize essential core documents required for site initiation, regulatory and core submissions, from site startup through study-end submissions • Perform CTRA operational deliveries and regulatory lead activities on assigned project activities • Review clinical trial study core documents for regulatory compliance • Contribute to and prepare technical components of regulatory core submissions, including EU Clinical Trial Regulation Part I and/or II • Contribute to or support agency interactions • Manage and operationalize day-to-day regulatory activities according to timelines, scope, budgets, and strategies • Act as a subject matter expert and troubleshoot project-related problems • Participate as regulatory support on multidisciplinary project teams • Identify and report process and risk areas • Maintain compliance and accuracy with relevant quality standards • Maintain current knowledge of applicable regulations, laws, and guidance covering pre- and post-market healthcare product requirements • Perform activities in compliance with corporate and divisional policies, standard operating procedures, and operating guidelines • Perform other duties assigned by management

🎯 Requirements

• Minimum of a BA or BS preferred • Experience working to applicable GxPs, including GVP, GCP, and ISO 14155 • Excellent presentation, documentation, influencing, and interpersonal skills, both written and spoken English • Team-oriented approach • Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, email, and Internet • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, for employees or applicants with disabilities

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