Principal Medical Writer - CRO

  • Competitive salary
  • Australia Victoria
  • Permanent
  • Life Sciences
Principal Medical Writer

NES Fircroft is seeking an experienced Medical Writer who will confidently lead medical writing projects across this dynamic and growing boutique CRO!

You'll provide project leadership across all development, writing & editing of scientific, clinical content, Investigator Brochures (IB), Clinical Trial Protocols, Participant Information Consent (PIC) and Clinical Study Reports, as well as ensuring medical accuracy & regulatory compliance across promotional tools. Developing SOPs, internal guidelines & best practice for content development.

An exciting opportunity to join a CRO with plenty of further career growth opportunities within as they continue to expand!

  • act as a scientific consultant and medical writer; provide scientific and regulatory support to clients and internal teams
  • provide scientific strategy on study designs; plan and develop Early Phase study designs/synopses/protocols, IBs
  • clinical data analysis, CSRs development based on international standard and sponsor’s unique requirements
  • quality control activities (regulatory documents, SOPs, SAP, AMIS, TFLs)
  • ensuring that study designs are adequate and meet study objectives while ensuring subjects' safety
  • participation in reviewing Early Phase protocols prepared by clients
  • accountable for scientific leadership and deliverable on assigned activities throughout the project conduct
  • submission of regulatory materials (FDA, Health Canada, HREC)
  • keep track of assigned documents/deliverables until the end of the study and deliver within required timelines; address and manage related issues.
  • independently prepare and present scientific material at internal and client calls
  • lead projects autonomously from beginning to the end
To be successful, you will have;
  • A positive 'can do' attitude
  • Suitably qualified with Medical, Life Science or equivalent degree(s)
  • Experience writing regulatory documentation including study reports & protocols
  • Thorough medical terminology knowledge & good understanding of clinical trial processes and ICH GCP guidelines
  • Excellent verbal & written communicator
  • Ideally experience in developing & delivering training programs within Medical Writing
  • Good understanding of drug development & awareness of regulatory affairs
  • Australian Citizen or Permanent resident

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

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