Relevant university degree desired Relevant certification completed, e.g., European Medical Writers Association (EMWA) Professional Development Program Excellent knowledge of MS Office (i.e. WORD, Excel, Outlook, PowerPoint, etc.) Extensive experience in regulatory and clinical medical writing Ideally knowledgeable about key indication and substance classes (e.g., oncology, antibodies) Advanced knowledge of the drug development process, relevant regulations, and the needs of relevant stakeholders Knowledge of US and EU content and format requirements for components of CTD and eCTD submission dossiers Fluent English skills, both written and verbal; you should speak German at least at a good conversational basis Structured work fashion, good analytical skills and attention to detail Candidates who can demonstrate the ability to manage up as well as down in the organizational line may be preferred



Die Stellenanzeige Senior Medical Writer (m/f) von via OPTARES GmbH & Co. KG wurde zuletzt aktualisiert am 29.05.2016.



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