Posted in Writing/Editing 30+ days ago.
Type: Full-Time
Location: Warsaw, Indiana
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 Sr. Medical Writer will be responsible to independently identify pertinent internal and external sources of clinical data and conduct literature searches of peer review publications and to 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 PMS 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, Risk Management and Development Engineering groups to verify and approve content of final Clinical Evaluation documentation. Prepare reviews of peer-reviewed literature for inclusion in Zimmer Biomet post-market surveillance documents. File work in the Clinical Evaluation archives, provide clinical data searches and documentation as a service to various functions within Zimmer Biomet.
Principal Duties and Responsibilities
Expected Areas of Competence
Education/Experience Requirements
Travel Requirements
Up to 5%
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: $107,000 - $120,000
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