Medical Writer

17 hours ago

Melbourne, Victoria, Australia Accelagen Pty Ltd Full time $80,000 - $120,000 per year

Join this rapidly growing global Clinical Research Organisation
for a chance move to the next step in your Medical Writing career

  • Hit the ground running with the potential to build a team of writers in the future.
  • Head office based in Hawthorn East however this role offers remote working
  • A fun & dynamic environment offering meaningful work & work/ life balance

About our business

We are a leading, locally positioned and globally adept Clinical Research Organisation (CRO) headquartered in the Melbourne suburb of Hawthorn East. We are working with innovative clients across the globe to make a tangible impact on the future of human health and wellness.

Celebrating 15 years in 2025, our experience is widely varied across the health, wellness and disease spectrum. We offer end-to-end services across Strategic Consultants, Clinical Trials, Regulatory Affairs & Biometrics.

We are a fast-growing business and currently have an opportunity for an experienced
Medical Writer
to join our team.

The Role

Reporting to the Head of Medical, you will contribute all aspects of medical writing in this innovative and hands-on role.

Key responsibilities of the role include but are not limited to:

  • Coordination of clinical project document writing.
  • Writing Clinical Study Protocols, Clinical Study Reports, and Investigators Brochures.
  • Writing technical documents like PSUR, DSUR, etc. based on international standards and templates.
  • Quality control activities of regulatory documents.
  • Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
  • Synthesise and integrate comments from both internal and external clients into documents.
  • Manage life cycle of documents from draft through development, to finalisation.
  • Developing training materials and conduct training for colleagues and may assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local staff or others.
  • May present on standard Medical Writing processes at full-service bid defence meetings.
  • Author of medical writing SOP, streamline medical writing processes and collaboration with other departments

About You

The desired degree qualified candidate will have the following:

  • A minimum of 5 years' experience in clinical trial regulatory writing, with a sufficient understanding of the clinical trial environment (GCP) as well as sufficient understanding of listings, tables and figures.
  • You have strong attention to detail and enjoy problem solving, with a high level of written and verbal communication. You are self-driven, resourceful and understand the importance of continuous improvement and life-long learning.
  • You may currently be in a Medical Writing role looking for a role where you can continue to utilise and develop your skills.

This position must be based in Australia and we are unable to sponsor potential candidates.

Why work for Accelagen?

  • An opportunity to change the world working for a highly regarded CRO
  • Working on globally recognised Clinical Research studies
  • 4 Wellness days off a year & a day off for your Birthday
  • Hawthorn East location, with free parking and hybrid/ flexible working
  • Career development opportunities within the organisation - we love to promote from within
  • Referral bonus – know someone very well rewarded for the intro

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