Writes and/or edits clinical documents for submission to the FDA and other regulatory agencies. Is an expert on current ICH Guidelines for clinical documents for regulatory submissions. Manages scheduling and tracking of documents, review process, and changes and finalization of documents. Interacts regularly with clinical teams to establish and review timeline for clinical study report completion. Works with clinical, data management and biostatistics staff to develop report formats and write final drafts of clinical study reports. Participates in review of clinical data interpretation for purposes of accurate report writing. May draft manuscripts, Investigator's brochures, Annual Reports, Protocols and package insert materials or promotional materials, as needed by individual project teams in Clinical Development. Manages work of contract writers. Develops SOPs and templates for the CTD, protocols, final reports, Annual Reports, and IBs.
Skills & Requirements
Graduate degree preferred. Degree should be in biological science, English or other relevant area. 5 to 7 years directly related medical writing experience. Outstanding writing, analytical and research skills a must. Ability to decipher complex clinical and statistical data. An overall understanding of the content and format of ISE and ISS journal specific format requirements is also expected. Knowledge and experience with document management systems is desirable, with proven ability to prioritize multiple tasks.
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