Associate Clinical Evidence Writer

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Cochlears 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 world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to peoples lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

The Opportunity

An exciting opportunity exists for an Associate Clinical Evidence Writer to join the Clinical Evidence team in Macquarie Park Sydney. You will play a key role in the curation analysis and dissemination of clinical evidence to drive scientifically rigorous and compliant evaluation of Cochlears products.

Reporting to the Director of Clinical Evidence this role partners with global stakeholders to maintain clinical documentation and support the continued registration of hearing implants and related medical devices across international markets. The Associate Clinical Evidence Writer is part of a dynamic virtual team responsible for producing documents of high commercial value for regulators and recipients.

Your responsibilities include:

• Develop document and maintain systematic literature reviews in line with agreed search criteria.
• Update literature review documentation as required under the EU Medical Device Regulation (EU MDR).
• Maintain and update Clinical Evaluation Plans (CEPs) Clinical Evaluation Reports (CERs) and associated regulatory submission documents including Summaries of Safety and Clinical Performance (SSCPs) in accordance with EU MDR requirements.
• Incorporate new data from postmarket surveillance published literature risk management activities and other relevant sources into clinical evaluation documents (typically on an annual cycle).
• Support the development and maintenance of Investigators Brochures (IBs) in accordance with internal procedures and templates.
• Maintain and update Clinical Evidenceowned repositories and documentation links including IB and CER directories.
• Review and edit documents for internal stakeholders supporting both regulatory and commercial audiences as required.

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 youll be able to demonstrate the following skills and experience:

• Clear and effective communication skills
• Ability to manage timelines and work in a fast-paced environment
• Experience with scientific databases (such as PubMed and Embase)
• High level of competency with Microsoft Office suite including Word Power-Point and Excel
• Demonstrated ability to critically evaluate synthesise and summarise complex information to produce highquality written documentation.
• Experience with/willingness to work across multiple time zones with the flexibility to engage outside standard office hours as required within a virtual team environment.
• Experience working in cross-functional teams
• Tertiary education in biology medicine audiology or clinical research.
• Experience working in compliance with procedures/regulations/fixed protocols

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

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. 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