Cochlear is the global market leader in implant hearing solutions. Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.
Are you passionate about creating clear, comprehensive documentation that makes a real impact? Cochlear, the global leader in implantable hearing solutions, has an exciting opportunity for a Clinical Operations Technical Writer to join our team. In this pivotal role, you will support the development and refresh of Standard Operating Procedures (SOPs) and other essential documentation for our Clinical Operations processes. Your work will ensure our procedures meet the highest regulatory and industry standards, directly contributing to the efficiency and effectiveness of our global operations. This role is perfect for a detail-oriented professional who thrives in a collaborative environment and is driven by the opportunity to make a meaningful difference in people’s lives.

Top Reasons to Apply:

• Contribute to a high-impact SOP Refresh project.
• Collaborate with a global team across multiple time zones.
• Support the development of process improvements in Clinical Operations.
• Flexible working arrangements available
• Fixed term part time opportunity - 3 days per week

The Opportunity
Cochlear has an opportunity for a fixed-term part-time Clinical Operations Technical Writer based in our Sydney, Macquarie office. In this role, the successful Clinical Operations Technical Writer will support the creation of SOPs and supporting documents for Clinical Operations processes, ensuring compliance with regulatory requirements and industry best practice.

Responsibilities include:

• Collate input from the extended project team.
• Author SOPs and associated documents (work instructions, guidance documents, templates, and forms).
• Facilitate review process and incorporate suggestions and edits.
• Ensure all documents are written and formatted according to prescribed templates and guidelines.
• Prepare documents and change forms for submission to Quality.
• Meet project-related timelines.

What makes this opportunity unique?
This role offers the chance to contribute to a high-impact SOP Refresh project, collaborate with a global team, and drive process improvements in Clinical Operations. You will be at the forefront of creating documentation that enhances operational efficiency and ensures compliance with global standards, all while working for a company dedicated to making a difference in people’s lives through innovative hearing solutions.
About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you’ll be able to demonstrate the following skills and experience:

Essential

• Bachelor’s Degree in Life Sciences, Technical Writing, or related field.
• Previous experience in a role within Clinical Operations.
• Strong understanding of the purpose and structure of SOP’s and supporting documentation.
• Experience writing technical documents e.g., SOP’s, work instructions, guidance documents etc.
• Familiarity with document management systems.
• Excellent organisational and project management skills.
• Demonstrated ability to work collaboratively in a team environment, working across multiple time zones.
• Good working knowledge of GCP requirements and the Regulatory requirements applicable to clinical investigations in at least one of the major jurisdictions, US, EU, Australia.

Ideal

• 3-5 Years experience and demonstrated proficiency in technical writing within the clinical operations, medical device, or pharmaceutical industry.
• Understanding of Cochlear’s current SOP structure and content relevant to clinical operations.

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

CochlearCareers

How we recognise your contribution
We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.
For more information about Life at Cochlear, visit www.cochlearcareers.com
At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We’re open to a conversation about what flexibility means for you.

• Collate input from the extended project team.
• Author SOPs and associated documents (work instructions, guidance documents, templates, and forms).
• Facilitate review process and incorporate suggestions and edits.
• Ensure all documents are written and formatted according to prescribed templates and guidelines.
• Prepare documents and change forms for submission to Quality.
• Meet project-related timelines