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Posted 4 days agoSenior Regulatory Medical Writer
at Fortrea
Remote
Responsibilities
- 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.
Requirements
- 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 .
- 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.
- 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.
Additional details
- 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.
- 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.
- 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,