Remote Country Start-Up Specialist – Regulatory & Activation

Syneos Health, Inc.; Illinois; Remote; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

Syneos Health in the United States seeks a Country Start-Up Specialist - Maintenance to manage country-level submissions, ensure SOP/WI compliance, and keep TMF and essential document packages up to date. The role anchors on distinguishing timelines, coordinating with the SSU Country Manager, and supporting site activation end to end.

Acting as liaison for the PM/SAM during start-up, you will prepare local EC/RA submissions, monitor submission milestones, and drive continuous quality improvement

Qualifikationen

• Experience in country-level submission processes and regulatory documentation.
• Familiarity with SOPs and work instructions in a regulated environment.

Aufgaben

• Ensure country-level quality deliverables within forecasted timelines.
• Maintain TMF and essential document packages per SOPs.
• Coordinate local EC/RA submissions and other regulatory communications.

Jobbeschreibung

Syneos Health in the United States seeks a Country Start-Up Specialist - Maintenance to manage country-level submissions, ensure SOP/WI compliance, and keep TMF and essential document packages up to date. The role anchors on distinguishing timelines, coordinating with the SSU Country Manager, and supporting site activation end to end.

Acting as liaison for the PM/SAM during start-up, you will prepare local EC/RA submissions, monitor submission milestones, and drive continuous quality improvement