Medical Writer

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Job Summary

Zimmer Biomet is a global medical technology leader. 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 Writer is primarily responsible for preparing and/or reviewing Clinical Evaluation Reports (CERs) for regulatory submissions including literature reviews 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 and/or review involves summarizing data found and drafting risk versus benefit analyses for review by Senior Medical Writer or designee. The scope includes products of Reconstruction, Sports Medicine, Trauma and Biologics Divisions.

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.
• Summarize findings and draft risk versus benefit analyses and conclusions, for review by Senior Medical Writer or designee, based on clinical and post market data in accordance with European Union guidance.
• 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 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 technical writing competence. 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.

Education/Experience Requirements

• BS/BA in biological science, engineering or a similar technical discipline preferred.
• 3+ years of related experience required with a bachelor's degree, or 6+ years required with a high school diploma (or equivalent).
• Experience required 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.

Travel Requirements

Up to 10%

Additional Information

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.

EOE/M/F/Vet/Disability

Compensation Range: $80,000 - $100,000/yr