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Medical Writer (f/m/d)
Aktualität: 10.01.2022


10.01.2022, ITM Oncologics GmbH
Medical Writer (f/m/d)
Write clear and concise clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, product labels (US PI, EU SmPC, CCDS), study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update / aggregate reports, risk management plans and integrated summaries of safety and efficacy Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate / resolve comments with all reviewers Perform literature-based research to support writing activities Support project teams by providing scientific and medical writing consultancy on various aspects, as requested (Renewals, Benefit / risk assessment, Independent Data Safety Monitoring Boards reports etc.) Provide medical and editing review of draft and final documents prepared by other writers before internal or external distribution Work in coordination and closed interaction with Global Medical Leads / Medical Experts, Safety Leads and Regulatory Leads within the organisation Organize and lead document development / review meetings Keep oversight of documents outsourced to other medical writing CROs Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes Response to query for medical expertise
Ideally at least four years' experience in a similar role Advanced degree in life sciences or relevant scientific / clinical / regulatory field Good experience in any complex diseases, oncology experience is preferred Ability to understand and interpret clinical and scientific data, and present results in an understandable manner to a variety of audiences Excellent command of the English language, both verbal and written communication skills Demonstrate keen attention to detail and faultless grammar and spelling Strong problem solving, analytical, organizational, good project and time management skills with proven ability to follow briefs and meet deadlines Team player who quickly creates positive and productive working relationships Experience in interventional trials Ability to prioritize multiple projects




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