FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

Col •legi Oficial de Metges; Valladolid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading medical organization is seeking a Medical Writer responsible for designing clinical plans and managing regulatory strategies for clinical trials. The role involves direct client interaction and collaboration with multidisciplinary teams to ensure timely project execution. Ideal candidates will have a strong background in regulatory writing and project management, contributing to drug development processes.

Formación

• Experience in writing regulatory documents (SA, PIP, ODD, IMPD, IB).
• Strong project management skills and ability to manage timelines.
• Excellent communication skills for liaising with clients and health authorities.

Responsabilidades

• Design clinical plans and regulatory strategies for trials.
• Manage client relationships and project timelines.
• Write regulatory documents to support drug development.

Conocimientos

Project Management

Regulatory Writing

Client Management

Educación

Degree in Life Sciences or related field

Descripción del empleo

As a Medical Writer, you will be in charge of the timely and correct execution of projects according to defined timelines :

• Being in charge of the design of clinical plans.
• Creation of the regulatory strategy for First-in-Human Clinical trials and / or MAA.
• Client and partner management : define milestones, planning and execution of tasks, manage timelines, project reporting.
• Liaison with health authorities for drug development procedures and / or Pre-submission meetings.
• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
• Direct contact with clients and interaction with multidisciplinary teams across the company, optimizing projects and development programs.

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