Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

The Medical Senior Writer is 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. Report preparation involves summarizing data and writing risk versus benefit analyses for products in a format defined to satisfy regulatory requirements. The Medical Senior Writer may occasionally prepare study protocols, investigational plans, manuscripts for publication or internal white papers. The scope includes products of the Spine Division.

Principal Duties and Responsibilities

• Identify pertinent internal and external sources of clinical data and conduct literature searches of peer review publications.


• Prepare Clinical Evaluation documents in accordance with European Union guidance and Zimmer Biomet internal procedures using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data. This will also include project management of CER or PSP activities across the clinical team.


• Summarize findings and write risk versus benefit analyses and conclusions based on clinical data, peer review publications, risk management files and post market data in accordance with European Union guidance. This may also include writing study protocols, investigational plans, manuscripts for publication or internal white papers.


• Work with Clinical Affairs, Regulatory Affairs, Post-Market Surveillance and Development Engineering groups to verify and approve content of final Clinical Evaluation documentation.


• Prepare reviews of peer-reviewed literature for inclusion in Zimmer post-market surveillance plan general and product-specific PSP reports.


• 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.

Expected Areas of Competence

• Excellent written and verbal communications skills.


• Demonstrated bibliographic research and editorial skills.


• Strong organizational skills, attention to detail and proofreading skills.


• Strong ability to interpret and disseminate relevant product information.


• Proficiency in MS Office applications and proficiency in or ability to learn EndNote or Reference Manager.


• Basic understanding of regulatory compliance for medical devices.


• Demonstrated project management skills.

Education/Experience Requirements

• A minimum of a BS/BA in biological science, biomedical engineering or a similar technical discipline required.


• A minimum of 5 years of experience as a medical or technical writer is required


• A background in clinical, regulatory or product engineering in the medical device industry is highly desired, with a strong preference to those with experience in the orthopedic industry.

Travel Requirements

• Up to 10%

Additional Information

EOE/M/W/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

Compensation Range: $91,600 - $100,600