[Hiring] Regulatory Medical Writer II @Fortrea

Role Description

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.

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.

Qualifications

• 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

Benefits

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?