Senior Medical Writer

<p><b>Full time. Remote. Ideal Locations: UK, Spain, Portugal, Greece, Poland, Italy, South Africa.</b></p><p></p><p>We are on a mission to deliver solutions that bring life-changing treatments to patients faster.</p><p></p><p>But we can´t do it alone.  </p><p></p><p>We are seeking an experienced <b>Senior Regulatory Medical Writer</b> and a <b>Medical Writer II</b> to lead authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner.</p><p></p><p>This is why we need you. Join Fortrea. Your job matters.</p><p></p><h1><span class="emphasis-2"><b>WHAT YOU WILL DO</b></span></h1><p></p><p>Embedded in the team of one of the world´s leading pharma companies, you will be one of the primary <i><b>Regulatory Medical Writers</b></i>, project leading the Development Cycle for high-complexity <b>Phase II-IV</b> clinical <b>regulatory</b> documents.</p><p></p><p>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.</p><p></p><p>From the variety of documents you will work on (Investigator´s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory responses, etc.,) your contribution will be essential developing:</p><p></p><ul><li><p><b>Protocols</b> and</p></li><li><p><b>Clinical Study Reports </b>(CSRs)</p></li></ul><p></p><p></p><h2>With minimal supervision, during <span class="emphasis-2"><b>Planning stage</b></span>, you will:</h2><p></p><ul><li><p>Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward.</p></li></ul><p></p><ul><li><p>Conduct Communication strategy meetings, to consolidate contributions from experts to produce a cohesive Shell Skeleton Report.</p></li></ul><p></p><ul><li><p>Facilitate Comment resolution meetings, to manage conflicting comments early and ensuring smooth protocol development.</p></li></ul><p></p><p></p><h2>During <span class="emphasis-2"><b>document development</b></span>, you will:</h2><p></p><ul><li><p>Maintain alignment with sponsor goals, project status and milestones across all teams.</p></li></ul><p></p><ul><li><p>Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions.)</p></li></ul><p></p><h2>Once <span class="emphasis-2"><b>final data</b></span> is received:</h2><p></p><ul><li><p><b>Critically interpret raw study data</b> (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs.</p></li></ul><p></p><h1><span class="emphasis-2"><b>WHO YOU WILL WORK WITH</b></span></h1><p></p><p>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.</p><p></p><p></p><h1><span class="emphasis-2"><b>YOUR EXPERIENCE</b></span></h1><p></p><ul><li><p>Advanced degree in life-sciences (PhD or Masters)</p></li></ul><p></p><ul><li><p>Minimum <b>4 years</b> of regulatory medical writing experience, including at least <b>2 years </b>as<b> medical writing project lead</b>.</p></li></ul><p></p><ul><li><p>Extensive experience and proficiency in writing and leading development of <b>CSRs</b> and <b>Protocols</b>.</p></li></ul><p></p><h1><span class="emphasis-2"><b>PERSONAL/TEAM SKILLS</b></span></h1><p></p><p><span class="emphasis-2"><b>You´ll be the nexus where multiple teams´ expertise converge</b></span>. 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. </p><p></p><p>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.</p><p></p><p>Integration within the client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.</p><p></p><h1><span class="emphasis-2"><b>A UNIQUELY DIVERSE CAREER</b></span></h1><p></p><p>At Fortrea, we empower you to shape your own career path.</p><p></p><p>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.</p><p></p><p>Your aspirations drive your journey with us. Where do you see yourself?</p><p>#LI-CV1 #LI-Remote</p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>