Experiences at ICON Clinical Research

Expanded medical and technical writing and publishing services for the fourth-largest clinical research organization (CRO). Directed daily activities of writers and epublisher. Supported all US clients with study documents for phase 1 through 4 clinical studies. Clinical disciplines and indications included, but were not limited to, cardiovascular, oncology, infectious diseases, inflammatory diseases, diabetes, and analgesia. Nonclinical areas included pharmacokinetics, toxicology, pharmacology, and CMC.
* Medical writing: Wrote, edited, revised, and reviewed clinical regulatory documents, including clinical study protocols and reports; investigator brochures; SAE narratives; informed consent forms; and two CTDs (one hard copy, one electronic). Wrote and edited meeting abstracts, slide presentations, posters, and biomedical manuscripts.
* Technical writing: Developed process development and CMC documentation for two CTD submissions. Reviewed and edited web site content.
* Other writing: Prepared, reviewed, and edited press releases.
* Infrastructure: Analyzed medical writing and publishing resource needs for ICON; developed new processes and document templates, style guide, and other infrastructure-related materials to support Medical Writing and Electronic Publishing; hired medical writers and an electronic publishing manager with extensive CoreDossier expertise; evaluated and prepared budgets for electronic publishing software, including CoreDossier and eCTDXpress; mentored writers and encouraged continuing education; acquired ISIToolbox and CoreDossier software for in-house publishing, and Documentum for document management and archiving.
* Administration: Developed budgets, assigned project resources, and met timelines; interfaced with other departments to ensure sufficient and appropriate input for Medical Writing projects; worked with Business Development and Contracts to create and review slide kits and market Medical Writing services; served on Senior Management, Process Development, Protocol Development, Document Control, and Product Review teams.
* Publishing: Used ISIToolbox to publish parts of CTD and eCTD and prepare clinical study reports for esubmissions (for example, hyperlinking, cross-referencing, pagination across volumes, and processing scanned documents for esubmissions); planned writing strategy for future esubmissions; worked with electronic publishing manager to publish a CTD and an eCTD.
* Management: Directed 7 medical writers, 1 technical editor, 2 medical writing consultants, and 1 electronic publishing manager....