Archiviertes Projekt - Medical Writer: Oncology (m/w/d)

Tasks:
Preparation and drafting of patient information/ consent forms, materials (patients/ physicians) regarding clinical trials:

In the context of oncological and pharma studies (clinical trials) based on the legal requirements (GCP, AMG, HWG) and the SOPs an WPs implementing them:

•Preparation of patient information / declarations of consent (Pat Infos) for newly starting studies as well as recruitment materials for an agreed timeline before the planned submission to the ethics committee by Novartis: This includes Pat Info for study participants and their relatives, if applicable, etc. as well as potentially required patient or HCP information material
oEstimated review cycles: 2-3 per package

•Preparation of amendments to patient information/declarations of consent (Pat Infos) for ongoing studies and, if necessary, for other recruitment materials at an agreed timeline before the planned re-submission to the responsible ethics committee by Novartis: This includes updates for Pat Infos for study participants and their relatives, if applicable, as well as potentially required material (see above)
oEstimated review cycles: 1-2 per package

•Preparation of patient information for the transfer from CT Directive to EU-CT Regulation


Required Skills:
• Completed studies in natural sciences
• 3-5 years experience in clinical science and or in writing of ICFs for
interventional studies, e.g. medical writing
• Knowledge of regulatory requirements (ICH-GCP, AMG, GCP, EU-CTR)
regulations of local / national health authorities
• Experience in writing of texts for patients in lay-language
• German native speaker, fluent in English