Join Our Team as a Senior Medical Writer – Shape the Future of Early-Phase Research
Beyond Drug Development is a pioneering, privately owned boutique CRO headquartered in Brisbane. Operating as a fully virtual organization, we specialize in early-stage product development—driving breakthrough innovations and accelerating transformative therapies for clients worldwide. Our approach combines scientific expertise with strategic interactions with regulatory authorities, ensuring informed, efficient, and compliant pathways from concept to clinic and beyond.
As our organization continues to grow, we are seeking an experienced and passionate Senior Medical Writer to join our Product Development team. This is an exciting opportunity to work at the forefront of clinical research, contributing to projects that advance innovative therapies and shape the future of healthcare.
What We Offer:
* Flexibility that works for you: Ideally full-time, but we welcome part-time arrangements (minimum 4 days/week).
* Collaboration: Work from home while staying closely connected with a dynamic, multidisciplinary team. Advertised as Brisbane but open to other regions of Australia.
* A values-driven culture: We prioritize people, ideas, and innovation. Your expertise and insights won't just be heard—they'll help shape our direction.
About the Role: You'll collaborate with and be an integral part of our team of experts in toxicology, regulatory affairs, and medical writing to provide strategic guidance to clients across all phases of clinical development. Our boutique CRO environment means you will have a real impact—working on diverse projects in a setting that values agility, creativity, and scientific excellence.
Why You'll Love Working Here:
* A collaborative, inclusive environment where your voice matters.
* Leaders who work alongside you, committed to advancing science and supporting the team.
* A chance to be part of a respected, niche CRO that offers something truly different from larger, traditional organizations.
If you're ready to take your medical writing career to the next level and thrive in a role that combines flexibility, autonomy, and meaningful impact, we'd love to hear from you.
What you will do
* Develop, review, and deliver high-quality medical writing and regulatory documents within agreed timelines, including clinical protocols, study reports, investigator brochures, gap analyses, Product Development Plans, and regulatory submissions (e.g., pre-IND/Scientific Advice briefing documents, IND applications).
* Provide strategic guidance to clients, leveraging deep expertise in medical writing, regulatory product development, study design, ICH guidelines, and GCP requirements.
* Engage with regulatory authorities as needed to support informed and efficient product development strategies.
* Lead project management activities for assigned regulatory and medical writing projects, ensuring timely completion within scope, budget, and deadlines. Responsibilities include coordinating cross-functional teams, organizing and chairing client meetings, preparing minutes, tracking budgets, and managing invoicing.
* Oversee external vendors for writing-related activities to ensure quality and compliance.
* Contribute to departmental growth by developing policies, Standard Operating Procedures, and providing regulatory and medical writing expertise to internal teams.
* Demonstrate professionalism and integrity in all interactions with management, colleagues, clients, and vendors.
* Perform additional duties as assigned and agreed upon.
Competencies/Experiences/Qualifications
* Bachelor's degree in life sciences or a related health discipline (or equivalent).
* Minimum of 5 years' experience in regulatory medical writing within a biotech or CRO environment.
* Proven track record as primary author for key regulatory and clinical documents, including clinical protocols, investigator brochures, clinical study reports, IND applications, pre-IND/Scientific Advice briefing documents, Product Development Plans, gap analyses, and other regulatory submissions.
* Solid understanding of clinical study methodology, design principles, and basic statistical concepts.
* Comprehensive knowledge of pharmaceutical industry practices, terminology, and processes.
* Familiarity with regulatory frameworks across US, EU, and Australian markets.
* In-depth knowledge of ICH guidelines and GCP requirements.
* Outstanding interpersonal, written, and verbal communication skills in English.
* Exceptional organisational skills with strong time management and follow-up capabilities.
* Ability to thrive in a fast-paced, virtual environment while collaborating effectively within cross-functional teams.
* Proficiency in electronic document management systems and Microsoft Office applications.
* Detail-oriented and quality-driven.
* Demonstrated experience or strong interest in exploring and applying emerging technologies -such as AI-assisted document development tools - to enhance efficiency while upholding the highest standards of accuracy and quality.
* Australian work authorisation is required for this position.
Bring your medical writing expertise and join a powerhouse team driving innovation in drug development at Beyond Drug Development (BDD).