Principal Medical Writer sponsor dedicated

MAI Fortrea Development Limited; Madrid; A distancia; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading global contract research organization is seeking an experienced Principal Medical Writer to develop high complexity clinical regulatory documents. This role requires a PhD or Master's degree, with a minimum of 6 years of eCTD submission writing experience. The ideal candidate will lead project teams, engage with stakeholders, and contribute to document strategy. Join a collaborative environment that nurtures personal growth and innovation, all while working remotely from Spain, UK, France, or Portugal.

Formación

• Minimum 6 years eCTD submission writing experience.
• 3 years as medical writing project lead.
• Experience leading content development for clinical summary modules.

Responsabilidades

• Lead authoring and development of clinical regulatory documents.
• Coordinate projects with multiple stakeholders.
• Contribute expertise to project strategy and document development.

Conocimientos

eCTD submission writing

Stakeholder management

Complex document development

Excellent communication skills

Collaborative teamwork

Educación

Advanced degree (PhD or Masters)

Descripción del empleo

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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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 authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner.

This is why we need you.

Join Fortrea. Your job matters.

WHAT YOU WILL DO

You will work for one sponsor, imbedded on their team. Under this framework, you will act as an :

Expert Contributor.

You will serve as an expert contributor on our partner’s project teams. You will use your expertise to write, advise, and coordinate development of complex clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, clinical summary modules and overview documents in CTD / eCTD format for regulatory submissions world-wide.

Strategist.

This job is tailor-made for Medical Writers passionate about leading development of key documents that inform and align with project strategy.

Project Manager.

You will be the nexus where multiple teams´ expertise converge. You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making to propel the document development cycle forward.

YOU NEED TO BRING…

Advanced degree (PhD or Masters)

Minimum 6 years eCTD submission writing experience, including 3 years as medical writing project lead.

Experience and proficiency in writing and leading development of a variety of clinical regulatory medical writing deliverables, including extensive experience leading content development for efficacy or safety clinical summary modules and drug applications across different regions.

Proven experience leading stakeholders / project teams through submission document development.

To drive development of documents of this scale forward, this role requires visibility, proactivity, collaboration / teamwork, and excellent communication skills. You must be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.

Integration within the partner´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At Fortrea, your career path is yours to shape. We empower our team to steer their own development. Where are you in your career journey?

• If you thrive in medical writing and want to remain deeply involved in science with high-profile clients, Fortrea is your destination.
• If you are coming to a point where you want to try management, we offer comprehensive training and support to prepare you for leadership roles.

Your aspirations drive your journey with us.

#LI-Remote #LI-CV1

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.