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Junior Regulatory Writer

Junior Regulatory Writer

Posted 20 August by Harris Lord Group
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Junior Regulatory Writer

An excellent opportunity has arisen with one of our long-standing clients. Operating as a CRO our client is looking to recruit a Junior Regulatory Writer on a permanent basis. The successful candidate will be responsible for generating clinical trial documentation, reports and initial clinical trial applications.

Key responsibilities will include preparing and handling a range of clinical documentation, report writing and supporting the Pharmacovigilance Group.

The company

Our client is a leading CRO which assists in all aspects of clinical research, and offers their specialist services globally. The working environment is highly supportive and there is an excellent change for development.

Experience

  • A science graduate with at least 6 months of industry experience in a GCP/ regulatory environment
  • Previous experience with scientific writing is essential
  • Knowledge of Oncology and ICH-GCP/FDA requirements would be highly beneficial
  • Understanding oncology study endpoints would be beneficial
  • Confident user of Windows based software programmes
  • Good knowledge of European Regulatory departments

Key words

CTAA, clinical, trials, data, record, SAE, RA Officer, regulatory, affairs, investigator brochures, consent forms, SAE, clinical summaries, protocols, SAE, adverse events, pharmacovigilance, writer, writing

Harris Lord is acting as an Employment Agency in relation to this role

Required skills

  • Clinical Research
  • Pharmacovigilance
  • Report Writing
  • Reports
  • Scientific Writing

Reference: 35911139

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