Overview
Full time. Remote. Ideal Locations: UK, Spain, Portugal, Greece, Poland, Italy, South Africa. We are on a mission to deliver solutions that bring life-changing treatments to patients faster.
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. You´ll spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor. Document types include Investigator’s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory Responses, etc., with your contribution essential in developing:
- Protocols
- Clinical Study Reports (CSRs)
With Minimal Supervision, During Planning Stage
- Lead kick-off strategy meetings to align geographically distributed teams, set 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 ensure 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 (gather inputs timely, consolidate contributions, answer questions).
Once Final Data Is Received
- Critically interpret raw study data (efficacy, exposure, endpoints, safety, etc.) into clear concise language in Protocols and CSRs.
Who You Will Work With
You will coordinate functional leads and reviewers from Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. You will also engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.
Your Experience
- Advanced degree in life-sciences (PhD or Master’s)
- 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. This role requires visibility, proactivity, collaboration, 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.
Integration within the client’s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.
A UNIQ UELY 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 SMEs and KOLs, and opportunities to help you thrive. Your aspirations drive your journey with us. Learn more about our EEO & Accommodations request here.
#J-18808-Ljbffr…