- Protocols and
- Clinical Study Reports (CSRs)
- 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.
- 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.
- 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 .
- 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.
- 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.
- Are you prepared to assume augmented responsibilities and adaptability across environments and therapeutic areas?
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Senior Regulatory Medical Writer, sponsor-dedicated - Maidenhead, Berkshire, United Kingdom - Fortrea
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
WHAT YOU WILL DO Imbedded 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. 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: