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Regulatory Specialist II
2 months ago
We are seeking a highly skilled Regulatory Specialist II to join our team at Syneos Health, Inc. This role will be responsible for ensuring the quality of deliverables at the country level, following project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
Key Responsibilities- Manage project timelines and ensure compliance with forecasted submission/approval timelines, tracking milestone progress in real-time.
- Monitor basic financial aspects of the project and escalate discrepancies in a timely fashion.
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI), ensuring timesheet compliance.
- Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
- Bachelor's Degree.
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to manage external vendors to contract effectively.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage multiple project budgets with increased complexity and value.
- Quality-driven in all managed activities.
- Good negotiating skills.
- Good problem-solving skills.
- Demonstrated ability to work independently as well as part of a team.
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.