Senior Medical Writer
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Job Summary
Sponsor-dedicated. Full time. Remote in the UK Greece Spain or Portugal.
We are on a mission to deliver solutions that bring life-changing treatments to patients faster.
But we cant do it alone.
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.
WHAT YOU WILL DO
Embedded in the team of one of the worlds 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.
Well 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 (Investigators Brochures Safety Narratives ICFs Efficacy Summaries Regulatory responses etc.) your contribution will be essential developing:
- Protocols and
- Clinical Study Reports (CSRs)
With minimal supervision during Planning stage you will:
- 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 you will:
- 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.
LOCATIONS
This is a full-time permanent job.
Our ideal locations are: UK Spain Portugal and Greece.
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
Youll 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 clients 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 SMEs and KOLs and opportunities to help you thrive.
Your aspirations drive your journey with us. Where do you see yourself
#LI-Remote
#LI-CV1
Learn more about our EEO & Accommodations request here.
Required Experience:
Senior IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
