Regulatory Specialist I

hace 1 día


Mexicali, Baja California, México Syneos Health Clinical A tiempo completo
About Syneos Health Clinical

Syneos Health Clinical is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health Clinical easier to work with and easier to work for.

Job Responsibilities
  • Provide quality deliverables at the country level, following project requirements and applicable country rules, with oversight from the SSU Country Manager.
  • Work within forecasted submission/approval timelines, ensuring compliance and tracking milestone progress in real-time. Escalate issues and provide clear rationale for delays, assisting with contingency plans to mitigate impact.
  • Monitor basic financial aspects of the project and the number of hours/tasks available per contract, escalating discrepancies in a timely fashion.
  • Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeping training records updated accordingly and ensuring timesheet compliance.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Key Functions
  • Local Submissions Specialist: Compile and/or review essential document packages for site activation, prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
  • Local Site ID and Feasibility Support: Provide support with site selection, ensuring the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Local Investigator Contract and Budget Negotiator: Support the SSUL to agree on country template contract and budget, assist in producing site-specific contracts, and negotiate budget and contract with site and Sponsor.
Qualifications

We are seeking an Associate's Degree or equivalent combination of education and training. The ideal candidate will have a good understanding of clinical trial process across Phases II-IV and ICH GCP, ability to interact effectively with investigative site personnel, and good organizational skills with attention to detail.



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