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MEDICAL WRITER EXPERT – REGULATORY AFFAIRS

Descripción de la oferta de empleo

We are looking for a Medical Writer Expert– Regulatory Affairs for our team of development, strategy and scientific writing expert unit. Someone who loves Science and wants to use their experience in a new challenging professional step.Main responsibilities:The Medical Writer will be in charge of the timely and correct execution of projects according to defined timelines:· Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD ,IB )· Writing eCTD Dossier clinical/nonclinical documents (M2)· Design of regulatory roadmaps· Regulatory strategy for MAA· Client and partner management: define milestones, planning and execution of tasks, manage timelines, project reporting· Liaison with health authorities for drug development procedures· Submission and management of applications through portals (CTIS, IRIS, ...)Requirements:Educational Background: Scientific/biomedical backgroundExperience: Minimum of 5-7 years in a similar role working in regulatory writing in pharma sector, or spin-off /start upSkills and Competencies:Strong knowledge of regulatory affairs.Excellent client-oriented communication skills and proactive mindset.Advanced proficiency in IT tools (MS Office Suite).Languages: Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.Why working at Asphalion?🖋️Permanent contract.📅 Flexible working schedule - Friday until 15.30h.💻 Homeoffice & Hybrid or Remote Model⚙️ Wide variety of projects, new challenges and experiences.↗️ Training and personal development program.📚English lessons.🤗 A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.🌍A highly & dynamic working environment with employees from more than 15 nationalities.🤸🏽Our people and their well-being are our priority: Physical, psychological and emotional well-being programme.🌳 Internal activities & RSC Activities✅ Equal Opportunity Employer
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Detalles de la oferta

Empresa
  • ASPHALION
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 01/12/2024
Fecha de expiración
  • 01/03/2025
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