Medical Writer II

3 weeks ago

Adelaide, South Australia Avance Clinical Pty Full time
Medical Writer II / Senior Medical Writer

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

Application Deadline: 08th August, 2025

Australian based, regulatory Medical Writer II or Senior Medical Writer required.
Remote, Hybrid, or Office-based working options available.

About Us

We're Avance Clinical, a Contract Research Organisation supporting drug development for the pharmaceutical and biotechnology industry. Our roots date back to the 1980s, and we are recognized experts in our field.

Why Join Us?

We offer a supportive, employee-centric culture with excellent long-term career prospects. We promote work/life balance with options for 100% WFH and hybrid arrangements. Over the past two years, we have doubled in size and promoted 25% of our staff in the last year.

You will join a high-performing team of 17 experienced Medical Writers & Editors, most holding PhDs. You'll work across diverse therapeutic areas and gain in-depth scientific exposure.

Role Overview

You will coordinate, write, and edit clinical documents including Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), and Clinical Study Reports (CSRs). You will serve as a primary technical contact for other departments and clients, mentor Medical Writers, and uphold quality standards.

Qualifications & Skills
  • Bachelor's degree in a scientific or relevant discipline.
  • Higher degree (desirable).
  • At least 2 years of Medical Writing experience, including clinical trial documents.
  • Minimum 3 years in the biotech/pharma/clinical research industry.
  • Strong report writing skills and experience with peer-reviewed publications.
  • Knowledge of ICH GCP, ICH E3 guidelines, medical terminology, and clinical trial processes.
  • Knowledge of statistics and data analysis (desirable).
  • Knowledge of pharmacokinetics (desirable).
  • Excellent time management and organizational skills.
  • Mentoring or leadership experience.
  • Excellent communication skills.
  • Proactive, reliable, and able to work independently.
  • Supportive of a positive team culture.
  • Proficient in MS Office.
Next Steps

If you're interested, please submit your CV and cover letter as one Word document. You must have full Australian working rights to be considered.

Alternatively, contact our Principal Talent Acquisition Specialist, Adrian Bedford, at 0406 574234 or Adrian.bedford@avancecro.com.

At Avance, we celebrate diversity and strive for an inclusive environment that empowers cultural, disability, LGBTI+, and gender equality.

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