Medical Writer II

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.

Overview

Australian based, regulatory Medical Writer II or Senior 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 1980's. 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 17 experienced Medical Writers & Editors most of which 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 Brochure's (IBs), Clinical Study Protocols (CSP), 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 mentors 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 2 years of experience as a MW with prior experience in preparation of IBs, CSPs, PICFs, CSRs or other clinical trial documents.
- Minimum 3 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 guideline, ICH E3 guideline, medical terminology and clinical trials 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 communications 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.
- Mentoring/leadership experience.

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 yourCV & 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 0406 574234 / Adrian.bedford@avancecro.com

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

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