Resultados de la búsqueda: 8 vacantes
...JOB SUMMARY
The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions...
...able to create a place where everyone feels like they belong.
Job Summary:
Syneos Health is looking for a detail-oriented regulatory attorney to join its Legal team. The successful candidate will be a self-starter with excellent judgment and significant experience...
...responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
May provide input to clinical development or regulatory teams within the Company, upon request.
May represent the Company at scientific meetings, upon request.
Qualifications...
...in the SAP and specifications.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of...
...qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate...
...members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality...
...provided by both Clinical and Corporate. Leads root cause analyses and the implementation of corrective actions required to meet regulatory requirements. Participates in meetings with clients on the management of quality issues on their projects.
JOB RESPONSIBILITIES...
...site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout. This may include patient...
