Medical Writing Lead

Excelya

France

Sur place

EUR 45 000 - 65 000

Plein temps

14 jours+

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Résumé du poste

Une entreprise dynamique et novatrice dans le domaine de la rédaction médicale cherche à recruter un Rédacteur Médical Senior. Ce rôle essentiel impliquera de gérer la coordination des documents cliniques et réglementaires, en collaborant au sein d'équipes transversales. Si vous êtes passionné par l'innovation en recherche clinique et souhaitez évoluer dans un environnement stimulant, cette position est faite pour vous.

Qualifications

Expérience en rédaction médicale ou scientifique.
Capacité à gérer plusieurs projets simultanément.
Compétences avérées en coordination de projets.

Responsabilités

Coordonner les documents cliniques et réglementaires.
Organiser des réunions de lancement (KOM) et de résolution de commentaires.
Rédiger des modifications de protocoles et préparer des documents réglementaires mineurs.

Connaissances

Organisation

Flexibilité

Communication

Formation

Master en Sciences de la Vie, Rédaction Médicale ou domaine connexe

Description du poste

Join to apply for the Medical Writing Lead role at Excelya

Join Excelya, whereAudacity, Care, and Energydefine who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Writing. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main activities :

The primary responsibility of the consultant is to coordinate clinical and regulatory documents falling under the scope of Local and Global Medical Affairs.

The consultant will act as the Sponsor's Medical Writing (MW) representative within cross-functional teams and in collaboration with the global medical writing service provider. They will serve as the key liaison between the Sponsor's internal teams (both global and local) and external medical writers.

The consultant will be responsible for the following activities:

Organizing Kick-Off Meetings (KOM) and comment resolution meetings for the projects under their responsibility
Reviewing outsourced documents for which they are the designated coordinator
Drafting synopses in collaboration with the Medical Director
Writing protocol amendments
Preparing minor regulatory documents
Supporting the workflow within the Electronic Document Management System (EDMS)
Assisting with formatting for documents outsourced to local providers

About the Job

Main activities :

The primary responsibility of the consultant is to coordinate clinical and regulatory documents falling under the scope of Local and Global Medical Affairs.

The consultant will be responsible for the following activities:

Organizing Kick-Off Meetings (KOM) and comment resolution meetings for the projects under their responsibility
Reviewing outsourced documents for which they are the designated coordinator
Drafting synopses in collaboration with the Medical Director
Writing protocol amendments
Preparing minor regulatory documents
Supporting the workflow within the Electronic Document Management System (EDMS)
Assisting with formatting for documents outsourced to local providers

Requirements

Key Responsibilities Breakdown:

Project coordination: 80-85%
Medical and regulatory writing: 15-20%

The consultant will manage projects across various therapeutic areas, both at the global and local level. The ability to handle multiple projects simultaneously and to reprioritize tasks in response to urgent needs is essential. Flexibility, organizational skills, and adaptability are key to success in this role.

Why join us ?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Seniority level