Senior Regulatory Medical Writer

Sponsor-dedicated. Full time. Remote in the UK, Spain, South Africa, Greece, Portugal or Hungary.

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 Senior Regulatory 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

Imbedded in the team of one of the world´s leading pharma companies, you will be one of the primary Regulatory Medical Writers, project leading the development cycle for high-complexity Phase II-IV clinical regulatory documents.

You will own the end‑to‑end medical writing process, from initial planning and cross‑functional coordination through drafting, review, and final delivery, ensuring alignment with project strategy, stakeholder expectations, and agreed timelines.

Your contribution will be essential authoring most study-level documents, for example:

• Protocols and protocol outlines
• Subject Information / ICF
• Lay summaries of clinical trial results
• IBs
• Regulatory briefing packages, responses

With minimal supervision, you will:

• Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward.

• Conduct communication strategy meetings and facilitate comment resolution meetings, to consolidate contributions from experts and to manage conflicting comments early, ensuring smooth document development.

• Maintain alignment with sponsor goals, project status and milestones across all teams.

• Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions.)

• Critically interpret raw study data (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs.

WHO YOU WILL WORK WITH

You will coordinate functional leads and reviewers from the Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. Additionally, you will engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.

YOUR EXPERIENCE

• Advanced degree in life-sciences, PhD or Masters

• Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead. This means independent authoring, proactively collaborating with stakeholders to author content, drive discussions, and manage the authoring/review process.

PERSONAL/TEAM SKILLS

You´ll 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.

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 client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At Fortrea, we empower you to shape your own career path.

Whether you are passionate about the medical writing scientific side, or aspire to leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you thrive.

Your aspirations drive your journey with us. Where do you see yourself?

Learn more about our EEO & Accommodations request here.

Originally posted on Himalayas