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ID: POS06186

Medical Writer (m/w/d)

Pharma & Biotech
Asap
6 Monate
Remote
K-Recruiting GmbH
Ansprechpartner:

Nadine Münch

+49 89 1890998-18

nadine.muench@k-recruiting.com

Medical Writer (M/F/D)

 

Tasks:

  • Medical Writing ICFs (Informed Consent Forms, texts for recruiting material for patients and physicians)
  • Preparation and drafting of patient information/ consent forms, recruitment materials (patients/ physicians) regarding oncology studies:
  • In the context of oncological 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 (PatInfos) for newly starting studies as well as recruitment materials for an agreed timeline before the planned submission to the ethics committee: This includes PatInfo for study participants and their relatives, if applicable, etc. as well as potentialy required patient or HCP information material. Estimated review cycles: 2-3 per package
  • Preparation of amendments to patient information/declarations of consent (PatInfos) for ongoing studies and, if necessary, for other recruitment materials at an agreed timeline before the planned re-submission to the responsible ethics committee: This includes updates for PatInfos for study participants and their relatives, if applicable, as well as potentialy required material (see above)Estimated review cycles: 1-2 per package

 

Qualification:

  • 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

 

Requirements: 

Start: 01.12.2022

Duration: until 31.05.2023

Capacity: 12,5 hours per week

Location: remote

 

Interesse geweckt? Auf gehts!
Ansprechpartner
Nadine Münch
+49 89 1890998-18
nadine.muench@k-recruiting.com