At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

As a Medical Writer you are primarily responsible for preparing Clinical Evaluation Reports (CERs) for regulatory submissions and Post-market Surveillance Plan literature reviews (PSPs) for analysis of existing product clinical performance.

Both involve conducting searches of peer-reviewed publications, national implant registries, risk management files and post market quality tabulations to compile relevant data.

The scope includes products of Reconstruction, Trauma and Biologics Divisions.

How You’ll Create Impact

• Identify pertinent internal and external sources of clinical data and conduct systematic literature searches of peer review publications.
• Prepare Clinical Evaluation documents according to the applicable regulations (including MDR (EU) 2017/745) and Zimmer Biomet internal procedures using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data.
• Summarize findings and draft risk versus benefit analyses and conclusions, for review by Medical Writing Manager or designee, based on clinical and post market data.
• Distribute reviewed final draft reports to Clinical Affairs, Regulatory Affairs, Post-Market Surveillance and Development Engineering groups to verify and approve content of final draft document.
• Prepare reviews of peer-reviewed literature for inclusion in Zimmer Biomet post-market surveillance (PMS) reports.
• Support the Manager or Team Leader for Audit activities including the participation in Audits as clinical evidence SME as needed.
• File work in the Clinical Evaluation archives, provide clinical data searches and documentation as a service to various functions within Zimmer Biomet, and provide verbal and/or written progress reports monthly.

What Makes You Stand Out

You have an analytic and strategic mindset combined with the ability to critically analyze and interpret scientific data as well as the ability to interpret and disseminate relevant clinical studies / medical product information.

As a highly organized individual, you function independently, you can work within tight deadlines and adjust to changes in priorities.

Fluent in English (written and spoken), you demonstrate excellent communication skills.

You are proficient in MS Office applications and EndNote or Reference Manager (or other similar software tools) and a good understanding of statistical methods.

Your Background

You hold a Bachelor’s degree or equivalent education in health, life sciences, engineering or a similar discipline required. MS and PhD preferred.

In addition you have a proven track record of at least 3 to 5 years of experience in medical writing, clinical affairs, regulatory affairs, or product engineering in the medical device industry, with a strong preference to those with similar work experience in the orthopedic medical device industry.

Demonstrated authorship of scientific publications in peer review journals will be an asset.

EOE/M/F/Vet/Disability