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, based in EU for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya's projects. Your Mission: * To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with sponsors' and Excelya's SOPs, guidelines and applicable legislation. * To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs). * To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality. * To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines). * To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers. * To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.
* Degree in Life Sciences. * At least 3 years of prover experience in medical writing. * Experience with writing of protocols, CSRs and CTDs, ICFs and lay summaries. * Fluent in English. * Previous experience in CROs is a plus. * Project management and coordination skills.
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