FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

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

Descripción de la vacante

A leading company is seeking a Medical Writer to oversee clinical project execution, regulatory strategy, and client management. The role involves creating key regulatory documents and liaising with health authorities to support drug development, ensuring timely project completion and optimization.

Formación

• Experience in writing regulatory documents like IMPD and IB is crucial.
• Ability to manage timelines and work with health authorities.
• Expertise in clinical planning and project optimization.

Responsabilidades

• Design clinical plans and regulatory strategy for trials.
• Manage client relationships and project milestones.
• Write essential regulatory documents to support drug development.

Conocimientos

Client management

Regulatory strategy development

Project reporting

Multidisciplinary team collaboration

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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