Medical Writer
Job Description
authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigational plan, informed consent document, clinical study report, investigator\'s brochure, clinical summary of pharmacology, clinical overview (efficacy and safety), briefing package/pre-meeting package and/or safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Periodic Adverse Drug Experience Report (PADER/PAER), Risk Management Plans (RMPs), and addendum to clinical overviews (aCOs) preferred . Experience in preparation of clinical/safety 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/safety 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
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Job Detail
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Job IdJD3094157
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear