FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

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

Descripción de la vacante

A leading company in healthcare is seeking a Medical Writer to oversee the design and execution of clinical projects. You'll be responsible for creating regulatory strategies and documents while managing timelines and liaising with clients and health authorities. The role demands strong project management skills and expertise in regulatory writing for various clinical applications.

Formación

• Experience in regulatory submissions and drug development.
• Proven capabilities in clinical project management.
• Strong written and verbal communication skills.

Responsabilidades

• Design clinical plans and write regulatory documents for drug development.
• Manage client relationships, project timelines, and reporting.
• Liaison with health authorities on drug development.

Conocimientos

Project management

Regulatory writing

Client management

Timelines management

Educación

Relevant 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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