Clinical Evidence Writer
Job no: 612137
Work type: Permanent
Categories: Clinical Studies, Oceania, Individual Contributor
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 people to Hear Now. And Always.
We are seeking a Clinical Evidence Writer reporting to the Clinical Evidence Manager to join our Global Headquarters in Sydney. In this role, the successful Clinical Evidence Writer will perform literature reviews and create literature summaries as needed to identify evidence gaps, and further support the registration of Cochlear’s devices by working closely with other members of the Clinical Evidence team to develop key submission and/or commercialisation documents, including Clinical Evaluation Reports (CERs).
- Perform literature reviews according to agreed search criteria, and document these in the Literature Search Plan and Literature Search Report, respectively, as needed to identify evidence gaps and/or assess the current literature
- Follow EU Medical Device Regulation guidelines for literature review methodology to format newly created and update existing reviews
- Write Clinical Evaluation Documents for certification and recertification of hearing implants and related devices by Regulatory bodies
- Liaise with the lead author of Clinical Evaluation Report (CER) and/or State of the Art (SOTA) documents and agree timelines for project delivery based on regulatory timing needs
- Review existing CERs and related documents and update them on an annual basis (or as required) with new data from Post Market Surveillance, published literature, risk management and other relevant data sources
- Review drafted manuscripts (external and internal) as requested for scientific content, compliance to scientific journal format, English grammar and punctuation, and Cochlear guidelines where applicable
- Maintain up-to-date records of key documents produced by the Clinical Evidence Team to support prospective planning and currency of documentation.
- Develop Investigator Brochures as required, per Cochlear’s procedure and template
- Develop and maintain a working knowledge of Cochlear’s product portfolio and databases
You Bring Your Skills and Experience
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:
- Excellent written and spoken communication skills, across multiple formats and audiences
- Experience with writing up study results
- Competency with word, power-point and excel
- Readiness to learn new skills
- Demonstrated ability to work both as part of a team and autonomously across multiple projects
- Demonstrated ability to critically evaluate and summarise scientific information
- Demonstrated ability to work cross-functionally and across time zones
- Experience with delivering projects according to timelines and working under pressure to meet deadlines
- Experience with scientific journal manuscript submissions
- Tertiary qualification in biology, medicine, audiology or clinical research
- Experience working in regulated environments, demonstrating compliance with procedures/regulations/fixed protocols
In turn, you will have the unique opportunity to work at Cochlear’s Global Headquarters with an onsite manufacturing site, across departments and geographies, to support safe, informed use of all Cochlear’s products by providing review and evaluation of available data to a range of external and internal audiences. You will also have the unique opportunity to gain experience and upskill Cochlear in new medical device regulatory guidelines.
Working for Cochlear:
For 40 years, Cochlear has been creating reliable products that continue to keep people connected to the world and to each other. We help people of all ages to hear in more than 180 countries around the world. Our technology connects people to life's possibilities and to the people who matter most. We have over 4000 employees globally dedicated to improving people's lives. To date, we have Invested over $2bil to date in research and development.
Cochlear can offer:
- The Work - A high impact job supporting world leading technology
- The Organisation – The global leader in implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives
Visit www.cochlearcareers.com for more information.
How to Apply:
Please submit your resume and a covering letter detailing your suitability for this role. All applications will be considered, and qualified candidates will be contacted.
Advertised: AUS Eastern Daylight Time
Anticpated Application Closing: AUS Eastern Daylight Time
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