Senior Medical Writer - Remote/Hybrid, Global Trials

Avance Clinical Pty Ltd.; Australia; Hybrid; AUD 90,000 - 135,000; Full time

Benefits offered by this job

WFH options

Hybrid work model

Career growth

Job summary

Avance Clinical Pty Ltd. is seeking a Medical Writer II or Senior Medical Writer to join a global, stable CRO with flexible work arrangements including remote, hybrid, or office-based options. The role requires 2+ years in medical writing, strong regulatory document skills, and a proactive, collaborative approach.

Australian working rights are essential. You will work on Investigator Brochures, CSPs, PICFs, CSRs, and other clinical documents, mentored by senior staff, in a team with PhD-level

Qualifications

• Bachelor's degree in a scientific discipline and at least 2 years as a Medical Writer.
• Minimum 2 years' MW experience with regulatory documents (IBs, CSPs, CSRs).
• Minimum 3 years in biotech/pharma/clinical research industry.
• Strong writing and editing skills with attention to quality.
• Knowledge of ICH GCP guidelines and clinical trial processes.

Responsibilities

• Coordinate, write and edit Investigator Brochures, CSPs, PICFs and CSRs.
• Serve as primary MW contact for Avance departments and clients.
• Mentor junior writers and maintain quality processes.
• Ensure documents meet regulatory requirements and timelines.

Skills

Medical writing

Regulatory writing

Mentoring

Time management

Communication skills

Education

Bachelor's degree in a scientific discipline

Master's degree or higher (desirable)

Tools

MS Office

Job description

Avance Clinical Pty Ltd. is seeking a Medical Writer II or Senior Medical Writer to join a global, stable CRO with flexible work arrangements including remote, hybrid, or office-based options. The role requires 2+ years in medical writing, strong regulatory document skills, and a proactive, collaborative approach.

Australian working rights are essential. You will work on Investigator Brochures, CSPs, PICFs, CSRs, and other clinical documents, mentored by senior staff, in a team with PhD-level