Clinical Documentation Specialist

2 months ago

Sydney, Australia Cochlear Ltd Full time

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.

The Opportunity

Cochlear has an opportunity for a Clinical Documentation Specialist based in our Macquarie Park site. In this role, the successful Clinical Documentation Specialist will provide essential operational and administrative support to our Clinical Evidence team ensuring the delivery of high-quality clinical documentation. You’ll have expertise in editing, formatting, and managing a wide range of critical documents, often via manual processes.

Responsibilities include:

- Edit, format, and perform quality checks on a variety of clinical documents, ensuring they meet our high standards and comply with relevant procedures and regulations. You will work closely with Clinical Evidence Writers, assisting in the development and timely delivery of Clinical Evaluation Plans and Reports, Literature Plans and Reports, Summaries of Safety and Clinical Performance, Investigator’s Brochures and State of the Art reports.
- Take charge of document transfers to new templates, update internal references, source external articles, manage our central EndNote library, and ensure accurate formatting across all documents.
- Actively participate in initiatives aimed at improving our processes and ensuring compliance with our Quality Management System. Your contributions will help enhance the clarity, quality, and consistency of our clinical evaluation documents.
- Coordinate reviews, approvals, and activities across multiple documents and team members for system-level projects. Develop and maintain a comprehensive dashboard to track projects, ensuring all team members are aligned and informed.

What makes this opportunity unique?

Contribute to critical research and evidence-gathering efforts that have a real-world impact on the quality of our products. Be part of a supportive team that values continuous improvement and personal development. Embrace opportunities to take on new challenges and expand your skills.

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
- Strong written communication and spoken English skills.
- Excellent and consistent attention to detail.
- High level of proficiency in MS Office.
- Competence in editing and proof-reading scientific documents.
- Systematic, disciplined approach to managing and tracking support requests and document status.
- Excellent interpersonal and communication skills with internal stakeholders and external customers.
- Flexible and adaptable with the ability to work as part of a virtual team.

Desired Skills
- Experience in the development of controlled documents in a regulated environment.
- Experience working as part of a virtual team, across time zones.

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.

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.

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

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