Global Medical Writing Director & Regulatory Strategy

Sironax; Victoria; On-site; AUD 230,000 - 320,000; Full time

Job summary

Sironax is seeking a Medical Writing Director to lead clinical and regulatory writing across global development programs, providing strategic, scientific, and operational direction. You will establish vision, standards, templates, and best practices for medical writing and oversee end-to-end authoring of protocols, CSRs, IBs, DSURs, and regulatory submissions.

This role requires cross-functional leadership, vendor management, and collaboration with Clinical Development, Regulatory Affairs, Data

Qualifications

• Advanced degree in life sciences (PhD/MD/PharmD/MS preferred).
• 10+ years of medical writing experience in pharma/biotech/CRO.
• Proven lead writer for protocols, CSRs, IBs, DSURs, and IND submissions.
• Experience with global regulatory submissions (FDA/EMA/ICH).
• Familiar with eCTD format and submission publishing tools.

Responsibilities

• Establish and lead the medical writing function, setting long-term strategy and standards across programs.
• Provide expert guidance on document strategy, data presentation, messaging, and regulatory expectations.
• Collaborate with Clinical Development and Regulatory Affairs to anticipate submission needs.
• Oversee and author planning, development, and delivery of regulatory and clinical documents.
• Lead vendor selection, budgeting, and performance oversight for writing activities.
• Drive templates, workflows, and electronic document systems; push for automation and digital tools.

Skills

Strategic leadership

Medical writing

Regulatory submissions

Project management

eCTD familiarity

Education

Advanced degree in life sciences

Tools

eCTD

MS Word

Document management systems

Job description

Sironax is seeking a Medical Writing Director to lead clinical and regulatory writing across global development programs, providing strategic, scientific, and operational direction. You will establish vision, standards, templates, and best practices for medical writing and oversee end-to-end authoring of protocols, CSRs, IBs, DSURs, and regulatory submissions.

This role requires cross-functional leadership, vendor management, and collaboration with Clinical Development, Regulatory Affairs, Data