FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

Col •legi Oficial de Metges; Murcia; Presencial; EUR 35.000 - 60.000; Jornada completa

Descripción de la vacante

A prestigious medical institution is seeking a skilled Medical Writer to oversee the execution of clinical projects. The role involves designing clinical plans, managing client relationships, and writing essential regulatory documents to support drug development efforts. The successful candidate will play a key role in ensuring compliance with health authority regulations and optimizing project outcomes through effective collaboration.

Formación

• Experience in clinical trials and regulatory submissions.
• Strong writing skills in regulatory documentation.
• Ability to manage client relationships and project timelines.

Responsabilidades

• Design clinical plans and create regulatory strategies.
• Manage projects, timelines, and client interactions.
• Write various regulatory documents and liaise with health authorities.

Conocimientos

Project Management

Regulatory Writing

Client Management

Liaison with Health Authorities

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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