Snr / Principal Medical Writer

3 weeks ago

Adelaide, South Australia Avance Clinical Pty Full time

We're seeking an experienced regulatory Medical Writer to join us at Senior or Principal level. You can work remotely (WFH) from anywhere in Australia.

14th March, 2025

Australian based Senior or Principal regulatory Medical Writer required.
Remote, Hybrid or Office based working are all options.

Who are we?

We're Avance Clinical, a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980s. If you already work in this industry, you'll know that we are experts in our field.

Why should you join Avance Clinical?

We have a great, employee-centric culture and offer excellent long-term career prospects. We believe in work/life balance and offer 100% working from home (WFH) and hybrid options. We've doubled in size this past two years and have promoted 25% of our people in the last 12 months.

You'll be joining a high-performing, supportive, established team of 14 experienced Medical Writers, most of whom have a PhD. You'll work on a diverse range of therapeutic areas and get to really explore the science behind a project. We're seeking people that thrive in a positive environment, who are inquisitive and keen to have a genuine opportunity to learn and grow in a business that is expanding.

Broad Purpose

You'll be responsible for the coordination, 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 (MW) range of services. The role also serves as a primary MW technical contact for other Avance departments and the client for any clinical study documents assigned to be prepared, as well as mentoring Medical Writers on MW tasks and maintaining quality processes.

Qualifications, Skills and Experience
  • Ordinary degree in a scientific or relevant discipline.
  • Higher degree in scientific or relevant discipline (desirable).
  • Minimum 3 years of experience as a MW with prior experience in preparation of IBs, CSPs, PICFs, CSRs, or other clinical trial documents.
  • Minimum 6 years of 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 guidelines, ICH E3 guidelines, medical terminology, and clinical trial processes.
  • Knowledge of statistics and data analysis and presentation methods (desirable).
  • Knowledge of pharmacokinetics (desirable).
  • Excellent time management and organisational skills.
  • Excellent oral and written communication skills.
  • Demonstrated initiative, reliability, and ability to work unsupervised.
  • Willingness to work in, and be supportive of, a positive and dynamic team culture.
  • Intermediate to advanced skills in MS Office suite.
What next?

As a growing business, we're looking for likeminded people to join us – we hope that's you.

  • To join our team, please submit your CV & cover letter as one Microsoft Word document.
  • You must have full Australian working rights to be considered.

Alternatively, you could pick up the phone and call our Principal Talent Acquisition Specialist Adrian Bedford at 0406 574234 or email Adrian.bedford@avancecro.com.

At Avance, difference is encouraged, it's celebrated, and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.

Medical Writer / Scientific Writer / Biotech / CRO / Clinical Research / Clinical Trials / Adelaide / Brisbane / Melbourne / Sydney / Perth / PhD / work from home / remote working.

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