Syneos Health
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.
Principal Clinical Trial Regulatory Affairs
🔥 0 minutes ago
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Syneos Health
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
• Collaborate as a Regulatory Subject Matter Expert with major functional area leads on Site Activation pathway issues. • Participate in strategic account and portfolio client meetings. • Develop and maintain strategic customer relationships and proactively assess client needs. • Ensure project deliverables meet internal and customer expectations, including projections, reports, updates, and risk assessments. • Define execution strategies for milestones and key deliverables with project leadership. • Prepare and present regulatory and submission strategy and status at client meetings. • Update plans and compile controlled document requirements in accordance with SOPs and sponsor processes. • Review clinical trial study core documents for regulatory compliance. • Coordinate and perform regulatory core submissions, including EU Clinical Trial Regulation Part I dossiers, and track submission packages. • Analyze CTA Competent Authorities/Ethics Committees regulatory considerations and Requests for Information. • Author regulatory documents for submission when required and agreed with the Sponsor. • Prepare clinical trial application dossiers for amendments and modifications throughout project lifecycle maintenance. • Perform Regulatory Impact Assessments, identify gaps, and communicate risk mitigation to Sponsors and project teams. • Oversee collation, quality review, and submission of country-specific applications. • Identify gaps in evidence supporting submissions and contribute to regulatory recommendations and decisions. • Review project budgets against milestones and manage scope, profitability, and out-of-scope work. • Act as liaison between customer leaders and senior management on regulatory tasks and issues. • Translate complex technical regulatory issues into plain language for nontechnical audiences. • Lead regulatory activities for projects with highly complex regulatory profiles. • Facilitate processes and communications within the CTRA team. • Contribute to new business development, proposals, and strategic client activities. • Support management in project and departmental review meetings. • Develop and deliver training programs and courses. • Transfer knowledge to entry-level employees and provide technical expertise in multidisciplinary teams. • Maintain compliance with quality standards, utilization targets, applicable regulations, and guidance documents.
🎯 Requirements
• Bachelor’s Degree required; higher degree preferred. • Subject matter expertise in current regulatory frameworks, including regulations and guidelines for non-interventional studies, clinical trials, and medical devices. • Experience working to applicable GxPs, including GVP, GCP, and ISO 14155. • Strong knowledge of clinical research management processes. • Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. • Previous experience in budgeting and quality management. • Ability to teach and mentor team members. • Ability to coach employees to reach performance objectives. • Ability to recognize and take appropriate action when employee performance is unacceptable. • Excellent written and spoken communication and interpersonal skills, with ability to influence, convince, and persuade. • Team-oriented approach. • Quality-driven approach to managed activities. • Strong negotiating and problem-solving skills. • Ability to provide quality feedback and guidance to peers. • Maintain current knowledge of applicable regulations, laws, and guidance documents covering pre- and/or post-market requirements for healthcare products.
🏖️ Benefits
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Career paths and employment opportunities • Team collaboration with specialized therapeutic or functional teams
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