Senior Medical Writer

3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Yseop specializes in artificial intelligence (AI) and is a recognized pioneer in Natural Language Generation (NLG) technology. Yseop is rapidly expanding globally, providing enterprise-level automation solutions for some of the world’s largest companies in a variety of industries including finance, pharmaceuticals and computer software. With its multi award-winning Language AI technology, Yseop is revolutionizing the way analysis and reporting is done. Yseop’s powerful and user‑friendly platform allows business users to seamlessly and quickly build and automate the generation of text reports from any structured data. At Yseop, our mission is to support companies through this digital transformation. We believe that our cutting‑edge artificial intelligence technology allows businesses to increase the efficiency of their operations and shift employee time spent on tedious tasks to more value‑added and creative work. So join Yseop and be part of an amazing adventure that is only at its beginning Team: We care about each other, inspire each other and encourage strong team spirit Trust: Trust is foundational. It empowers our employees and customer relationships. Innovation: We love to innovate in ways that delight our customers Customer Centric: We exceed customer expectations and aspire to create true partnerships. Fast: We practice agility, prioritize simplicity and we are proactive We are building a diverse and inclusive team - and we need your help So join us to build tomorrow, today, 🚀 Are you passionate about creating high‑quality, impactful medical writing while working with cutting‑edge technology? Medical Writer with Safety Writing Experience Your responsabilities will be : Define content requirements and templates for automating the generation of pharmacovigilance regulatory documents. Collaborate with the product team to translate regulatory requirements into structured, configurable content models that support automation. Ensure that generated documents meet ICH, EMA, FDA, and other global regulatory standards for PV reporting. Provide expert guidance on data‑driven document generation, structuring narratives based on PV safety databases and case reports. Review and validate AI‑generated content for compliance, accuracy, and consistency. Work closely with UX/UI teams to ensure the medical writing workflow is intuitive and efficient for end users (pharmacovigilance professionals and medical writers). Monitor regulatory updates and industry trends to adapt and improve automation models. Required Qualifications & Experience Extensive experience (5+ years) in medical writing focused on pharmacovigilance regulatory documents. Deep understanding of Clinical documents & global PV regulations (ICH E2E, E2C, E2F, GVP modules, FDA, EMA, and MHRA guidelines). Experience working with PV safety databases (e.g., Argus, ArisG, Veeva Vault Safety) and structured data for case reporting. Knowledge of document automation, structured authoring, or AI‑generated content is a plus. Ability to collaborate cross‑functionally with product managers, engineers, and regulatory teams. Strong attention to detail and the ability to define clear, standardized templates and content rules. Preferred Skills Familiarity with authoring tools and automation platforms for regulatory writing. Experience in technology‑driven projects, such as integrating medical writing with AI/NLP tools. Strong problem‑solving skills and an interest in streamlining and improving regulatory document workflows. Expertise in medical writing, Clinical Documents & PV documents. Familiarity with AI‑driven or data‑to‑text technologies is a plus. Strong editing and quality assurance skills. Excellent communication and collaboration abilities. Ability to manage multiple projects and meet strict deadlines. Yseop is an equal opportunity employer. We believe diversity is a strength and fosters innovation. We are committed to enabling everyone to feel included and valued at the workplace. All qualified applicants will receive consideration for employment without regard to age, color, family, gender identity, marital status, national origin, physical or mental disability, sex (including pregnancy), sexual orientation, social origin, or any other characteristic protected by applicable laws. #J-18808-Ljbffr