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Synteract is an innovative CRO providing full-service, Phase I-IV services to biopharma companies in bringing new medicines to market. We align our operational excellence, therapeutic expertise and the right technology to support each clients clinical development needs. Over its nearly 30-year history, Synteracts leadership has been proven in the core dev...
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The Medical Writer is responsible for writing, editing and reviewing clinical study documents according to global regulatory guidance, templates, style guides and standard operating procedures (SOPs). Clinical study documents may include but are not limited to study protocols and amendments, investigator brochures (IBs), informed consent forms (ICFs), annual safety reports, clinical study reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS/ISE), and other sections of regulatory applications (IND, IDE, NDA, BLA and PMA submissions). Other scientific documents (including but not limited to manuscripts, abstracts, posters) may also be developed.
Specific Tasks Would Include
Qualifications
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