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Senior Medical Writing Expert

hace 2 semanas

Cartagena, Murcia, España beBeeRegulatory A tiempo completo
Medical Writer - Regulatory Affairs Senior Officer

We are seeking an experienced medical writer to join our team of development, strategy, and scientific writing experts. This role is ideal for someone passionate about science and eager to leverage their experience in a new, challenging professional environment.

Main Responsibilities:
  1. Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
  2. Preparing eCTD dossier clinical/nonclinical documents (M2).
  3. Designing regulatory roadmaps.
  4. Developing regulatory strategies for MAA.
  5. Managing client and partner relationships: defining milestones, planning, executing tasks, managing timelines, and project reporting.
  6. Communicating with health authorities regarding drug development procedures.
  7. Submitting and managing applications through portals (CTIS, IRIS, etc.).
Requirements:
  • Educational Background: Scientific or biomedical background.
  • Experience: Minimum of 4 years in a similar regulatory writing role within the pharma sector, or in spin-offs/startups.
  • Skills and Competencies: Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
  • Technical Skills: Advanced proficiency in IT tools (MS Office Suite).
  • Languages: Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.
Benefits:
  • Permanent contract.
  • Home office & hybrid or remote model (located anywhere in Spain).
  • Variety of projects, new challenges, and experiences.
  • Training and personal development programs.
Others:

This role offers a unique opportunity to work with a talented team of professionals and contribute to the development of innovative products. If you are a motivated and experienced medical writer looking for a new challenge, we encourage you to apply.