Job Description

The Medical Writer is responsible for drafting and editing variety of documents related to clinical study, medical and regulatory documents, abstract and manuscript, slide and poster presentation. He/she carries out medical writing activities interfacing with other stakeholders and works in compliance with applicable procedures, requirements and timelines. This is a fully remote and home based role in either Poland, Serbia, Hungary or Bulgaria. Some of what you will do: Draw up, edit and review preclinical/clinical documents such as CSRs, study protocols, ICFs and other medical and regulatory documents Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations Prepare regulatory and preclinical/clinical documents for drug development and registration activities Manage documents to produce submission-ready content for customers Perform literature searches and reviews as necessary to obtain background information for the development of documents Create and maintain audit trail of all document changes Ensure the quality and accuracy of documents in English Participate in meetings as required Ensure correct archiving of files and documents Requirements: Master\'s degree in biomedical/scientific disciplines At least 2+ years of previous Medical Writing experience Knowledge of medical concepts and terminology Good knowledge of the ICH-GCP guidelines and the methodology of clinical research Fluent in English, specific knowledge of biomedical English is required Planning and organizational skills Communication skills We offer a competitive salary with other benefits and opportunity to develop your professional career with a growing company. Please read the information notice on the processing of personal data in the candidate\'s information section of our company website. Powered by JazzHR JzdUb1R2I8

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