What You Can Expect

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

• Proficient in English – written and spoken. Please note that it is essential to submit your CV in English, as proficiency in the language is a key requirement for this role. Unfortunately, applications in other languages cannot be considered.
• Excellent written and verbal communications skills
• Demonstrated technical and medical writing competence
• Strong organizational skills, attention to detail and proofreading skills
• Understanding of statistical methods
• Ability to critically analyze and interpret scientific data
• Have an analytic and strategic mindset
• Ability to work within tight deadlines, adjust to changes in priorities
• Ability to function independently
• Ability to identify problems and research possible solutions
• Takes actions that are best for the company versus his or her individual unit
• Encourages and supports information sharing and collaboration across teams and departments
• Demonstrates sound business ethics; shows consistency among principles, values and behaviors.
• Strong ability to interpret and disseminate relevant clinical studies / medical product information.
• Proficiency in MS Office applications and proficiency in or ability to learn End Note or Reference Manager or other similar software tools needed for performing the job.
• Basic understanding of regulatory compliance for medical devices.

Your Background

• Please note that it is essential to submit your CV in English, as proficiency in the language is a key requirement for this role. Unfortunately, applications in other languages cannot be considered.
• Minimum of a Bachelor’s degree or equivalent education in health, life sciences, engineering or a similar discipline required. MD, MS and Ph D preferred.
• Demonstrated authorship of scientific publications in peer review journals will be an asset.
• 3-5 years of experience in medical writing, clinical affairs, regulatory affairs, or product engineering in the medical device industry required, with a strong preference to those with similar work experience in the orthopedic medical device industry.
• In lieu of the medical device industry experience, 3-5 years as a professor or senior investigator in a healthcare related field, with a demonstrated record of research and scientific publications.

Travel Expectations