Senior Medical Writer

About Fortrea

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 and a Medical Writer II 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

Embedded 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. We’ll trust you to spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor. Your contribution will be essential in developing a variety of documents, including Investigator’s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory Responses, Protocols and Clinical Study Reports (CSRs).

During Planning Stage

• Lead Kick-off strategy meetings to align geographically distributed teams, setting goals, milestones, and critical path forward.
• Conduct Communication strategy meetings to consolidate contributions from experts to produce a cohesive Shell Skeleton Report.
• Facilitate Comment resolution meetings to manage conflicting comments early and ensuring smooth protocol development.

During 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.)

Once Final Data Is Received

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.
• Extensive experience and proficiency in writing and leading development of CSRs and Protocols.

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?

Key skills/competency

• Senior Medical Writer
• Regulatory Medical Writing
• Clinical Regulatory Documents
• Protocols and Clinical Study Reports (CSRs)
• Document Development
• Project Leadership
• Data Interpretation
• Cross-functional Collaboration
• Stakeholder Management
• Advanced Life Sciences Degree