SSU & Regulatory Specialist - Sponsor Dedicated - Paris Area
il y a 3 semaines
We are seeking a highly skilled SSU & Regulatory Specialist to join our team in Paris Area. The successful candidate will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.
Key Responsibilities:- Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
- Associate's Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good organizational skills and good attention to detail.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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