ICON Hiring Medical Writer – All Levels

ICON Hiring Medical Writer – All Levels

17 May, 2022

The Role

General Medical Writing (Sr Medical Writer)

  • Write clinical trial reports and other regulatory documents
  • Experience in writing CSRs, Protocols, Investigator Brochures, DSURs, PSURs (safety documents), submission documents
  • Provide additional writing and editing services as required (e.g. for publications)
  • Advise on the content and format requirements for clinical reports and regulatory documents.

Narrative Writing (All levels)

  • Write patient narratives for serious adverse events and drop-outs due to non-serious adverse events;  write the reports of clinical trials and other regulatory documents (including) according to ICON or client-specified formats
  • Provide additional writing and editing services (e.g. for publications) as required
  • Assist in the production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions

Candidates are expected to

  • Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
  • Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
  • Responsible for the daily management of assigned medical writing projects
  • Liaise with project managers and statisticians to ensure the timely implementation of activities related to the production of reports
  • Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems)
  • Participate in the training and supervision of new and junior medical writers
  • Represent Medical Writing at internal and external meetings
  • Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks where applicable.

What you need

  • Bachelors degree in a life science/health related sciences, or equivalent
  • Medical/Technical writing experience of 3 to 14 years in a clinical research setting
  • Outstanding written and verbal interpersonal skills
  • Ability to work effectively and cooperatively with other team members
  • Understanding of clinical research, the drug development process, and applicable regulatory guidelines.

Apply through this Link

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