Principal Medical Writer sponsor dedicated

The job description is generally well-structured and informative, but it can benefit from improved formatting for clarity and engagement. Minor adjustments include better use of HTML tags for headings and lists, removing redundant tags, and enhancing readability. Here's a refined version:

Principal Medical Writer Sponsor Dedicated, Madrid

Client: MAI Fortrea Development Limited

Location: Madrid, Spain

Job Category: Other

EU work permit required: Yes

Job Details

Views: 2

Posted: 25.04.2025

Expiry Date: 09.06.2025

Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Full time. Remote. UK, France, Spain or Portugal.

We are on a mission to deliver solutions that bring life-changing treatments to patients faster. But we can't do it alone.

We are seeking an experienced Principal Medical Writer to lead the authoring and development of high-complexity clinical regulatory documents critical to our partner's strategic projects.

What You Will Do

• Work for one sponsor, embedded on their team, acting as an expert contributor.
• Write, advise, and coordinate the development of complex clinical regulatory documents such as Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, and clinical summary modules in CTD/eCTD format for worldwide regulatory submissions.
• Lead development of key documents that inform and align with project strategy.
• Manage writing projects, coordinate with stakeholders, steer discussions, and facilitate decision-making to advance document development.

Qualifications

• Advanced degree (PhD or Masters).
• Minimum 6 years of eCTD submission writing experience, including 3 years as a medical writing project lead.
• Experience leading the development of clinical regulatory documents, especially efficacy or safety modules across regions.
• Proven ability to lead stakeholders and project teams through submission processes.

Skills and Attributes

• Visibility, proactivity, collaboration, and excellent communication skills.
• Comfort in leading team discussions, managing complex tasks, and engaging stakeholders.
• Adaptability across environments and therapeutic areas.

A Unique and Diverse Career

At Fortrea, your career is yours to shape. We support your development whether you aim to stay involved in science or move into management. Join us to make a global impact in clinical trials and drug development.