Medical Writer

Location: Nashville, TN OR NJ, TN OR NJ
Date Posted: 09-08-2016
Experience required: 8-10 years.
• Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory documents.
• Development and updating of Investigator’s Brochures, Clinical Study Protocols, and other regulatory documents
• Analysis, interpretation, and accurate presentation of information or data in text, table, or figure format
• Provide dedicated scientific authoring expertise to both the development and research groups.
• May need to liaise with external services and review documentation generated elsewhere (e.g., Clinical Research Organisations [CROs], subsidiaries, co-development partners), and internal support staff (e.g., for the preparation of tables, illustrations, and appendices).
• Quality-checking documents for agreement between in-text information and the source data
• Prepare reports, manage review cycles, and incorporate comments as appropriate.
• Provision of overall medical writing support for ongoing programs

At least a bachelor’s degree in Computer Science, Engineering or related field or an equivalent in education is required for this position.
We are an Equal Opportunity Employer.
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