Regulatory Medical Writer II

Fortrea; Portugal; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

Fortrea is seeking a Regulatory Medical Writer II to own high-complexity clinical regulatory documents across Phase II-IV. You will manage the full document lifecycle, from planning and stakeholder engagement through drafting, review and final delivery, collaborating with cross-functional teams globally.

The role requires 3 years of regulatory medical writing experience, at least 1 year leading MW projects, and strong knowledge of ICH guidelines.

Qualificações

• 3 years of regulatory medical writing experience.
• At least 1 year leading medical writing projects.
• Experience independently authoring and managing clinical regulatory documents.
• Knowledge of ICH guidelines and regulatory requirements.

Responsabilidades

• Lead high-complexity Phase II-IV document development.
• Manage full document lifecycle from planning to final delivery.
• Collaborate with cross-functional teams across regions.
• Ensure timelines and comments are resolved to move projects forward.

Conhecimentos

Regulatory writing

Project leadership

ICH guidelines

Scientific communication

Stakeholder management

Formação académica

Bachelor in Life Sciences

PhD preferred

Descrição da oferta de emprego

Full time. Remote in the UK, South Africa, Greece, Portugal.

Ready to take ownership of complex regulatory documents while working directly with some of the world's leading pharmaceutical companies?

At Fortrea, we help bring life-changing treatments to patients faster.

To do that, we need experienced Medical Writers who can lead document development, align stakeholders, and translate complex science into clear, high-quality regulatory content.

Join Fortrea. Your work matters.

What You´ll Do

As a Regulatory Medical Writer II, you'll take ownership of high-complexity Phase II-IV clinical regulatory documents that support critical development programmes.

You’ll manage the full document lifecycle, from planning and stakeholder engagement through drafting, review and final delivery.

Your Work Will Include

• Authoring protocols, protocol outlines, ICFs, investigator brochures, lay summaries and regulatory briefing packages.


• Leading document planning, review and approval activities across geographically distributed teams.


• Interpreting efficacy, safety, exposure and endpoint data to develop clear scientific content.


• Building alignment between cross-functional stakeholders and facilitating efficient document development.


• Managing timelines, resolving comments and ensuring projects move forward as planned.

Who You´ll Work With

You’ll collaborate closely with experts across:

• Biostatistics


• Data Management


• Programming


• Clinical Leadership


• Project Physicians


• Global Medical Writing teams across Europe, the Americas and Asia-Pacific

You’ll become a key partner in the document development process, helping teams work together to deliver high-quality regulatory submissions.

What You Bring

• 3 years of regulatory medical writing experience


• A minimum of 1 year leading medical writing projects


• Experience independently authoring and managing clinical regulatory documents


• Knowledge of ICH guidelines and regulatory requirements


• Strong scientific communication and stakeholder management skills
  
• Degree in Life Sciences. PhD preferred

WHY JOINING FORTREA?

This is an opportunity to work in a sponsor-focused environment where Medical Writers play a visible role in decision-making and document strategy.

You’ll gain exposure to global development programmes, collaborate with experienced stakeholders across multiple functions, and continue developing your project leadership capabilities.

A Uniquely Diverse Career

Whether you want to deepen your scientific expertise or progress towards senior and leadership roles, Fortrea provides the training, support, and professional network to help you grow.

Your career path is yours to shape. Where could it take you?

Learn more about our EEO & Accommodations request here.