Regulatory Medical Writer II

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.

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.

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.

• 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

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.

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