Principal Medical Writer sponsor dedicated

TN France; Rueil-Malmaison; À distance; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a Principal Medical Writer to lead the creation of high-complexity clinical regulatory documents. This full-time remote position offers the chance to work across various therapeutic areas and make a significant impact on drug development. The ideal candidate will have substantial experience in regulatory submissions and a strong background in medical writing. Join a forward-thinking organization dedicated to advancing clinical trial development and enjoy opportunities for career growth and leadership development.

Qualifications

• 6+ years of eCTD submission writing experience.
• Proven experience in developing regulatory medical writing deliverables.

Responsabilités

• Lead authoring of high-complexity clinical regulatory documents.
• Manage writing projects and coordinate with stakeholders.

Connaissances

Regulatory Medical Writing

Leadership

Communication

Collaboration

Formation

PhD or Masters

Description du poste

Principal Medical Writer sponsor dedicated, Rueil-Malmaison

Client:

MAI Fortrea Development Limited

Location:

Remote (UK, France, Spain, or Portugal)

Job Category:

-

EU work permit required:

Yes

Job Reference:

3bf0706d85b6

Job Views:

1

Posted:

25.04.2025

Expiry Date:

09.06.2025

Job Description:

Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development experience. We provide solutions across more than 20 therapeutic areas in over 90 countries, transforming drug and device development worldwide.

Position: Full-time, remote (UK, France, Spain, or Portugal)

We seek an experienced Principal Medical Writer to lead the authoring of high-complexity clinical regulatory documents essential for strategic projects.

Responsibilities include:

• Serving as an expert contributor on project teams, developing documents such as Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, and regulatory submission modules in CTD/eCTD format.
• Leading the development of key documents that align with project strategy, managing writing projects, coordinating with stakeholders, and facilitating decision-making.

Qualifications:

• Advanced degree (PhD or Masters)
• Minimum 6 years of eCTD submission writing experience, including 3 years as a project lead
• Proven experience in developing regulatory medical writing deliverables, especially efficacy or safety modules for drug applications worldwide
• Strong leadership, communication, and collaboration skills

Integration within the partner's team and adaptability across environments and therapeutic areas are essential.

Career Development: Fortrea offers opportunities for deep involvement in science, management training, and leadership development, supporting your career aspirations.

Join us in revolutionizing clinical trial development and making a global impact. Please ensure you have the necessary work permits if applicable. Applications should be submitted via the 'Apply now' button. For more information, visit our Blog.