Senior Regulatory Medical Specialist

1 week ago

Sydney, New South Wales, Australia beBeeMedical Full time $90,000 - $125,000
Regulatory Medical Writer Opportunity

We're seeking an experienced regulatory medical writer to join our team.

As a regulatory medical writer, you will be responsible for coordinating, writing and editing of Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), Clinical Study Reports (CSRs) and any other clinical study documents required as part of the medical writing service range. The role also serves as a primary technical contact for other departments and clients for any clinical study documents assigned and mentors medical writers on MW tasks and maintaining quality processes.

Responsibilities
  • Coordinate, write and edit IBs, CSPs, PICFs, CSRs and other clinical study documents
  • Serve as primary technical contact for other departments and clients
  • Mentor medical writers on MW tasks and maintain quality processes
Requirements
  • Ordinary degree in a scientific or relevant discipline
  • Higher degree in scientific or relevant discipline desirable
  • Minimum 2 years experience as a medical writer with prior experience in preparation of IBs, CSPs, PICFs, CSRs or other clinical trial documents
  • Minimum 3 years experience in the biotechnology/pharmaceutical/clinical research industry
  • Strong research report writing skills and/or demonstrated experience in writing peer reviewed journal articles
  • Knowledge of ICH GCP guideline, ICH E3 guideline, medical terminology and clinical trials processes
  • Excellent time management and organisational skills
  • Excellent oral and written communications skills
  • Demonstrated initiative, reliability and ability to work unsupervised
Benefits
  • Opportunity to work remotely from anywhere in Australia
  • Employee centric culture and excellent long term career prospects
  • 100% working from home options

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