Medical Writer Specialist

hace 2 meses


Barcelona, Barcelona, España Col·legi Oficial de Metges A tiempo completo

About the Role

The Medical Writer Specialist will be responsible for the timely and accurate execution of projects within the defined timelines at Col·legi Oficial de Metges.

Main Responsibilities:

  • Design and develop clinical plans to support drug development.
  • Develop regulatory strategies for First-in-Human Clinical trials and/or Marketing Authorization Applications (MAA).
  • Manage client and partner relationships, defining milestones, planning, and executing tasks, managing timelines, and project reporting.
  • Collaborate with health authorities for drug development procedures and pre-submission meetings.
  • Write regulatory documents to support drug development, including Summaries of Product Characteristics (SA), Product Information (PI), Overall Developmental Document (ODD), Investigational Medicinal Product Dossier (IMPD), and Investigational Brochure (IB).
  • Write electronic Common Technical Document (eCTD) Dossiers for clinical documents.
  • Establish and maintain direct contact with clients and interact with multidisciplinary teams across the company to optimize projects and development programs.

About the Company

Col·legi Oficial de Metges is a professional organization dedicated to promoting the interests of physicians and advancing the field of medicine.


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