Medical Writer Specialist

il y a 3 jours


Paris, France Ipsen Temps plein

Join to apply for the Medical Writer Specialist role at IpsenAre you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.Why Ipsen?Patient‑Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.Employee Care: We care for our employees, who are the ambassadors making a real difference.Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast‑moving, game‑changing organization.About The RoleThe Medical Writer Specialist is responsible for generating consistently high‑quality clinical documentation content and can work across multiple accounts and projects seamlessly. The role is a scientific expert in the allocated therapy areas and can accurately incorporate strategic concepts into projects while guiding others.Key ResponsibilitiesManage the preparation of regulatory documents such as CSRs, briefing documents, meeting requests, and clinical modules.Lead writing/editing of complex clinical dossiers/safety reports.Review documents to ensure compliance with documentation quality standards and regulatory requirements.Plan and create timelines to produce assigned documents.Project DeliveryAble to work across multiple projects and accounts simultaneously.Demonstrate a thorough understanding of timelines, budgetary constraints, and scopes of work.CommunicationUnderstand the purpose and role of communications in the wider therapy area and commercial landscape.Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital).QualificationsLife sciences degree, preferably MSc or PhD.Minimum 5 years of medical writing experience in either a CRO or pharmaceutical company.Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines, and key statistical concepts.Experienced writer of clinical protocols (IS and NIS), study reports (IS and NIS), and regulatory dossier level documents.RWE medical writing experience is an advantage.Previous experience in a medical communications agency or industry is also considered.English fluency.If you feel that this could be the right next step for you, we would be delighted to engage with your application. Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. #J-18808-Ljbffr


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