Location
- United Kingdom
Category
The role
You'll lead the planning and preparation of clinical regulatory documents for client teams in clinical development, operations, biostatistics, regulatory, and program management. This senior role involves managing timelines, coordinating cross-functional contributors, facilitating review feedback, and ensuring documents meet client and agency guidelines. You'll work remotely on a full-time basis, producing protocols, study reports, investigator brochures, and module documents to support drug development under brisk timelines.
At a glance
- Education
- Bachelor's Degree
- Experience
- 5+ years
- Level
- Senior
Tools and skills
Tools
Skills
Structured Content ManagementProactivityAdaptabilityVaccinesProtocol DevelopmentTemplate CreationContent CreationInfectious DiseaseCustomer focusMedical WritingConflict managementLean AuthoringReference ManagementComment ResolutionStyle GuidesRegulatory SubmissionsLiterature SearchesInvestigator BrochuresNegotiationICH GuidelinesClinical Study ReportsDocument ManagementMotivationUS Regulatory RequirementsData InterpretationMessaging DevelopmentOrganizationQuality ControlTimeline ManagementProject ManagementCommunicationCollaborationAttention to DetailClinical Regulatory DocumentsOncologyIndependence

