Medical Writer Specialist
hace 2 meses
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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