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 cant 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.

Imbedded in the team of one of the worlds 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 endtoend medical writing process from initial planning and crossfunctional 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.

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.

• 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.

Youll 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 clients team is crucial requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

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 SMEs and KOLs and opportunities to help you thrive.

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

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