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The Senior Medical Writer is expected to deliver high quality regulatory documents that meet ICH standards, project timelines, and client specifications. The responsibility of the Senior Medical Writer includes the management and preparation of a variety of clinical documents including protocols, clinical study reports, narratives, and investigator brochures for Phase I to IV clinical trials run by Covance globally. The Senior Medical Writer is also responsible for preparing clinical summary documents, including Integrated Summaries of Safety and Efficacy for NDAs and MAA in eCTD format. The Senior Medical Writer is expected to acquire a competency in the use of Documentum and associated electronic publishing tools.
• Extensive Experience with writing protocols, CSRs, narratives, investigator brochures, ISE/ISS, and other clinical documentation.
• Experience in data handling and data analysis.
• Good written and verbal communication skills.
• Ability to write fluent and grammatically correct English with an appreciation of the differences between UK English and American English.
• Good word-processing skills.
• Good organizational and time management skills.
• Pays attention to detail.
• Ability to work to tight timelines while maintaining accuracy.
• Ability to work to a variety of client-driven specifications.
• Good team player.
• Familiarity with Quality Assurance and Quality Control procedures.