Medical Writer II / Senior Medical Writer

About This Role

This role involves the coordination, writing, and editing of essential clinical study documents, serving as a primary technical contact for medical writing tasks, and mentoring other medical writers. It suits an experienced medical writer with a scientific background who thrives in a positive and dynamic team culture within the biotechnology and pharmaceutical industry.

Responsibilities

• Coordinate, write, and edit Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), Clinical Study Reports (CSRs), and other clinical study documents
• Serve as a primary medical writing technical contact for other Avance departments and clients for assigned clinical study documents
• Mentor Medical Writers on medical writing tasks and maintaining quality processes

Requirements

• Ordinary degree in a scientific or relevant discipline
• Minimum 2 years of experience as a Medical Writer 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 guideline, medical terminology, and clinical trials processes
• Excellent time management and organisational skills
• Mentoring/leadership experience
• 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
• Full Australian working rights

Nice to have:

• Higher degree in scientific or relevant discipline
• Knowledge of statistics and data analysis and presentation methods
• Knowledge of pharmacokinetics

Benefits

• Employee-centric culture
• Excellent long-term career prospects
• Work/life balance
• Opportunities for promotion

Important Details

• Work format: Remote, Hybrid, or Office-based working are all options

Application Process

• Submit your CV and cover letter as one Microsoft Word document

About the Company

Avance Clinical is a Contract Research Organisation offering specialised services supporting drug development for the pharmaceutical and biotechnology industry. Founded in the 1980s, the company has doubled in size over the past two years.