Principal Medical Writer
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Job Summary
Full time. Remote in the UK Spain Portugal or Greece.
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 Principal Medical Writer to lead authoring and development of high complexity clinical regulatory documents. You will work fully dedicated to one of our key strategic clients a Top 10 global pharmaceutical company.
This is why we need you. Join Fortrea. Your job matters.
WHAT YOU WILL DO
You will work sponsor dedicated embedded on their team. Under this framework you will act as an:
Expert Contributor.
You will serve as an expert contributor on our partners project teams at portfolio level. You will use your expertise to write advise and coordinate development of complex clinical regulatory documents including:
- 2.73 Efficacy and 2.74 Safety summaries
- Clinical Study Protocols
- Clinical Study Reports
- Investigator Brochures
- Full document overview in CTD/eCTD format for regulatory submissions world-wide.
Strategist.
This job is tailor-made for Medical Writers passionate about leading development of key documents that inform and align with project strategy.
Project Manager.
You will 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.
YOU NEED TO BRING
- Advanced degree (PhD or Masters)
- Minimum 6 years eCTD submission writing experience including 3 years as medical writing project lead.
- Experience and proficiency in writing and leading development of a variety of clinical regulatory medical writing deliverables including extensive experience leading content development for efficacy or safety clinical summary modules and drug applications across different regions.
- Proven experience leading stakeholders/project teams through submission document development.
TEAM LEAD SKILLS
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 partners team is crucial requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.
A UNIQUELY DIVERSE CAREER
At Fortrea your career path is yours to shape. We empower our team to steer their own development. Where are you in your career journey
- If you thrive in medical writing and want to remain deeply involved in science with high-profile clients Fortrea is your destination.
- If you are coming to a point where you want to try management we offer comprehensive training and support to prepare you for leadership roles.
Your aspirations drive your journey with us.
#LI-Remote
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Learn more about our EEO & Accommodations request here.
Required Experience:
Staff 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
