Description
Syneos Health is seeking a Country Regulatory Specialist with NAMER submission expertise to join their team. The successful candidate will be responsible for providing quality deliverables at the country and site level, following project requirements and applicable country rules.
Job Responsibilities
- Provide expert knowledge of RA/EC processes, requirements, and timelines, and maintain current knowledge of applicable regulations and guidelines.
- Provide country-level SME knowledge at the pre-award stage to support robust business development presentations.
- Provide country-level SME knowledge during the site-selection process to support the selection of appropriate sites.
- Maintain intelligence on country-specific start-up timelines and provide strategic recommendations to project teams.
- Forecast submission and approval timelines at the project level, track milestone progress, analyze delays, propose mitigation plans, and escalate risks.
- Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions.
- Serve as the country-level regulatory SME point of contact through the life of assigned projects.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) in compliance with SOPs and Customer requirements.
- Develop or support the creation of local country regulation training materials.
Additional Qualifications
- Minimum of a BA or BS preferred.
- 3-4 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience.
- Detailed understanding of clinical trial process across Phases I-IV and ICH GCP.
- Detailed understanding of clinical trial submission processes per country and local regulations.
- Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155).
- Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality.
- Strong presentation, documentation, influencing, and communication skills.
Benefits
- Company car or car allowance
- Health benefits, including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time