Job Information
Zimmer Biomet Senior Medical Writer (m/f/d) in Winterthur, Switzerland
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
In this role, you’ll lead the development of scientific content including CEP, CER, and SSCP. You’ll conduct literature and NJR reviews and edit materials for accuracy. Responsibilities include sourcing clinical data, preparing documents, and managing CER/PMS activities. You’ll collaborate with various departments to review and approve documentation and provide literature reviews and data services.
How You'll Create Impact
Controlling the writing, reviews and maintenance of controlled documentation in accordance with regulatory requirements (including CEP, CER and SSCP)
Managing requests from Notifying Bodies
Identification of relevant internal and external sources of clinical data for Zimmer Biomet products which are necessary for the fulfilment of regulatory requirements.
Designing literature and data registry searches using relevant keywords, executing the searches.
Managing the writing, editing, documenting, and publishing of clinical research articles, white papers and selected website content on Zimmer Biomet products.
Providing an inter-departmental information liaison and the handling of clinical research requests, technical documentation and support for publications and technical presentations
What Makes You Stand Out
Knowledge of regulatory compliance for medical devices
Excellent English written and verbal communications skills.
Additional languages are an advantage.
Computer proficiency in MS Office applications and proficiency in or ability to learn tool for managing bibliographies, citations, and references.
Knowledge of the ethical publishing standards of the American Medical Writers Association (AMWA) and/or the European Medical Writers Association (EMWA).
Skilled in working closely with authors and publishers, with a strong ability to interpret and disseminate relevant product information.
Your Background
Bachelor’s degree in health, life sciences, engineering or equivalent required
Five or more years of proven professional experience in clinical audit, medical writing, systematic review, and evaluation of clinical data, with particular expertise in orthopaedics is required.
Strong professional background in medical writing and knowledge of regulatory compliance for medical devices.
Professional experience in response to Notify Bodies enquiries
Additional 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.
Expertise in clinical research methodology, tools, and processes
Comprehension of statistical methods and ability to critically analyse and interpret scientific data.
Strong organizational skills, attention to detail, and ability to multitask in a fast-paced environment
Travel Expectations
Up to 5%.
EOE/M/F/Vet/Disability