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 recognized.

　　What You Can Expect

　　As a senior member of the Medical Writing Team, the Medical Writing Team Leader will assume a supervision role over a group of medical writer team members ensuring timely and high-quality in the execution of the tasks assigned to his/her direct reports. The Medical Writing Team Leader is still directly responsible for managing the typical activities of a Medical Writer, such as: identifying pertinent internal and external sources of clinical data and conducting literature searches of peer review publications. Prepare Clinical Evaluation documents following 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 following 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 the 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, and provide clinical data searches and documentation as a service to various functions within Zimmer Biomet.

　　How You'll Create Impact

　　Manages the writing, editing, documenting and publishing clinical research articles, white papers and selected internet content on Zimmer Biomet products and technologies.

　　Functions as an interdepartmental information liaison and manages requests for clinical research, technical documentation, and support of publications and technical presentations.

　　Manages the writing, reviewing and maintenance of controlled documentation according to regulatory requirements

　　Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirements

　　Design literature and data registry searches using relevant key words, execute the searches

　　Support the Manager for Audit activities including the participation in Audits as MW SME as needed

　　Supervise Medical Writers in planning, coordinating and reviewing work assignments together with the Manager. In case of potential issues, recommends and acts upon appropriate solutions, in agreement with the Manager

　　Support the Manager for the definition of clear goals and objectives each year in line with Zimmer Biomet strategy and to help the team members in achieving career goals.

　　What Makes You Stand Out

　　Minimum of a Bachelor’s degree or equivalent education in health, life sciences, engineering or a similar discipline required.

　　Master and PhD degree preferred.

　　Five or more years of documented professional experience in clinical investigation, medical writing, systematic review and clinical data appraisal.

　　Advanced Microsoft Office Suite and proficiency in or ability to learn tool for managing bibliographies, citations and references

　　Background in clinical, regulatory or product engineering in the medical device industry desired, with a strong preference to those with experience in the orthopedic industry.

　　Your Background

　　Excellent written and verbal communication skills.

　　Strong bibliographic research and editorial skills.

　　Knowledge of ethical publication standards of the American Medical Writers Association (AMWA) and/or European Medical Writers Association (EMWA).

　　Knowledge of regulatory compliance for medical devices.

　　Demonstrated project management skills.

　　Skilled in working closely with writers and publishers.

　　Strong ability to interpret and disseminate relevant product information.

　　Knowledge of clinical research methodology, tools & processes .

　　Understanding of statistical methods.

　　Travel Expectations

　　Up to 5%.

　　EOE/M/F/Vet/Disability