Medical Writer

TCS is hiring -

Job Location –

Experience Range –

Responsibilities:

• Overall ~5 years of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigation plan, informed consent document, clinical study report, investigator’s brochure, clinical summary of pharmacology, clinical overview (efficacy and safety), briefing package/pre-meeting package preferred.
• Experience in preparation of clinical documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies
• Clear, concise and scientific style of writing, with attention to detail
• Strong analytical skills and expertise in writing and review of scientific/clinical documents
• Good knowledge of clinical research domain, ICH GCP principles, Common Technical Document (CTD) structure and regulatory requirements
• 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.