Medical Writer / Content Creator (Bilingual German)
Paradigm is looking for a highly organized and detail-oriented Medical Writer / Content Creator (Bilingual German) for our client based in the Pacific Northwest. This is a fully remote West Coast based contract role. Then ideal candidate will be well versed in preparing documents that are in accordance with regulations, standards, and guidelines for medical devices, and have an understanding of the levels of evidence required to achieve regulatory goals. Having an understanding of the requirements for US FDA, EU medical device regulations, and Good Clinical Practices will also be critical to this role. Experienced with literature reviews and various publication databases including PubMed. Usability engineering processes during the development of new devices would be a preferred past experience. Ability to read and write German is a must.
Type: 3-6 month contract, Full-Time
Location: Remote, preferably based within one hour of the West Coast
Pay Rate: DOE
In this role, you will:
* Write coherent and engaging procedural content for a medical diagnostic device
* Work closely with the R&D Engineering Team in the Life Sciences space
* Create procedure content for a variety of documents including Instructions for Use (IFU) and Directions for Use (DFU) docs.
* Deliver content in English and German.
* Digest content in German and/or German to English translations on which to base content creation.
* Provide copy to and orchestrate development with a design agency
* Knowledge of FDA regulatory requirements as well as EU medical device regulations (e.g., required info, icons, etc.)
* Create procedure documents based on content and specifications provided by subject matter experts
The ideal candidate will have:
* Bachelor's degree in a relevant field with 3+ years of previous medical writing experience (within the medical device field preferred)
* Fluency in German; able to create medical content in German as well as translate existing content from English to German
* Strong medical writing and content creation background
* Experience creating procedural documents for IFU/DFU, ideally for a medical device
* Understanding of the requirements for US FDA, EU medical device regulations, Good Clinical Practices
* Previous experience in the Biotechnology/Life Sciences industry or in a Clinical laboratory will be an advantage
* Ability to work independently
* Strong proficiency with MS Office, especially Excel, Word, and PowerPoint, SharePoint
* Comfortable interacting with R&D Engineers, User Research, Product Development, and Marketing stakeholders
About Us, Paradigm
Want to love Mondays? It's possible when you love what you do. Paradigm is a San Diego staffing agency dedicated to finding the perfect job for candidates. We're connected with some of the most innovative tech companies around, giving our employees that competitive edge needed in today's job market.
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