Regulatory Affairs Senior Specialist - Trial Transparency Liaison - FSP EMEA
Core
Senior Regulatory Affairs Specialist acting as a Trial Transparency Liaison, managing global clinical trial registration, result posting, and document redaction for pharmaceutical and biotech clients.
Role type
Senior IC Regulatory Affairs Specialist (Clinical Trial Transparency)
Builds
Global clinical trial transparency deliverables (registrations, results, redacted documents) for sponsors
Domain
Pharmaceutical/Biotech / Clinical Trials / Regulatory Affairs
Required skills
Clinical trial transparency regulations, CTIS management, Clinicaltrials.gov registration, ICH guidelines, Commercially Confidential Information (CCI) identification, Regulatory submissions, Project process development, Contract scope analysis, Medical terminology, Statistical concepts, Budgeting/forecasting
Preferred skills
Experience in transparency positions, Local language proficiency, Adobe Acrobat Pro, Leadership of transparency activities
Technologies
CTIS, Clinicaltrials.gov, Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat Pro
