Job description

Authoring/editing of clinical documents and/or safety documents. Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of the clinical/safety documents within established timelines with adherence to applicable guidelines and processes, using appropriate checklists. Assist senior writers to facilitate effective interactions and information exchange/communication among co-authors and reviewers as appropriate Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards

Skills Required

Key Skills

• CLINICAL DOCUMENTS
• SAFETY DOCUMENTS
• REGULATORY
• PSUR

Other Information