Description
Syneos Health is seeking a Clinical Trial Regulatory Specialist to join their team in Belgrade, Serbia. As a Clinical Trial Regulatory Specialist, you will perform assigned activities within the CTRA team, providing delivery and expertise in regulatory submissions, site initiation, and study end related submissions.
Job Responsibilities
- Prepare technical components of regulatory core submissions, such as EU Clinical Trial Regulation Part I and/or II
- Conduct Quality Control reviews of documents and track until final submission or delivery to client
- Attend client meetings as needed and build client relationships
- Identify and report on areas of process and risk
- Ensure personal compliance with relevant quality standards and achieve utilization targets
- Maintain current knowledge of applicable regulations and guidelines
Qualifications & Requirements
- Minimum of a BA or BS degree
- Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
- Excellent presentation, documentation, influencing, and interpersonal skills
- Proficient computer skills in Microsoft Office Suite, web-based systems, and email
- Ability to travel approximately 10%
What We Offer
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture where you can authentically be yourself