At Excelya, we don't just work-we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience. Now, we're calling on curious minds and courageous spirits to step into a career-defining role in Medical Affairs. Ready to make an impact that travels the globe? Let's talk., At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient's journey. Here, you're not just doing a job-you're becoming a key part of something bigger. So, if you're ready to excel with purpose, let's write the next chapter together
We are seeking a Freelancer Senior Medical Writer, experienced with medical devices for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya's projects. The position is fully remote and the candidates can be based in every EU country or Armenia. Your Mission: * Preparation of PMCF, CER, CEP, PMS. * Review of relevant documents. * Consultation and gap analysis on transition from MDD to MDR. * Responses to queries from regulatory authorities. * Perform literature search. * Appraise literature search data. * Ability to interpret, evaluate, and translate medical research findings.
* Degree in Life Sciences. * At least 4-5 years of experience in medical writing. * Experience in medical device-related documents (CEP/CER/PMCF/PSP). * Fluent in English. * Knowledge of French language is a plus. * Submissions to FDA is a plus (for medical devices). * Regulatory consultation is a plus.
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