Senior Clinical Writer

Job description
Role Summary:

We are seeking a skilled Senior Clinical Writer to join our team. As a senior clinical writer, you will be responsible for authoring and editing clinical documents, including protocols, informed consent documents, clinical study reports, investigator's brochures, and safety documents.

Key Responsibilities:
• Authoring and editing of clinical documents, including protocols, informed consent documents, clinical study reports, investigator's brochures, and safety documents.
• Ensuring adherence to established timelines, regulatory guidelines, and applicable standards, styles, guidelines, and processes.
• Peer review/quality review of clinical/safety documents within established timelines with adherence to applicable guidelines and processes, using appropriate checklists.
• Assisting senior writers in facilitating effective interactions and information exchange/communication among co-authors and reviewers as appropriate.
• Maintaining and developing current knowledge of regulatory guidelines, technological advances, and industry standards.
• Assisting senior writers in training and mentoring activities as applicable.

Requirements:
• Overall 2+ years' of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents.
• Experience in preparation of clinical/safety documents necessary for national and international regulatory submissions to the US, European, and other regulatory agencies preferred.
• Experience in writing and review of scientific/clinical documents preferred.
• Knowledge of clinical research domain, ICH GCP principles, and regulatory requirements preferred.
• Effective coordination and presentation skills - good organization and time management skills.
• Exceptional interpersonal, verbal, and written communication skills.
• Computer literate: knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etc.
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