FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

Col •legi Oficial de Metges; Sevilla; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

A leading company in healthcare is seeking a Medical Writer to oversee projects related to clinical plans and regulatory strategies. The role involves managing timelines, client interactions, and writing essential regulatory documents to support drug development processes. This position requires strong project management and regulatory expertise in a dynamic environment.

Formación

• Experience in regulatory writing for clinical trials.
• Strong project management skills.
• Ability to engage with health authorities.

Responsabilidades

• Design clinical plans and create regulatory strategy.
• Manage timelines and client communications.
• Write regulatory documents to support drug development.

Conocimientos

Regulatory writing

Project management

Client management

Clinical planning

Educación

Degree in Life Sciences

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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