Fortrea is hiring a Principal Medical Writer to lead the authoring and development of high-complexity clinical regulatory documents. In this pivotal role, you will work fully dedicated to one key strategic client, a Top 10 global pharmaceutical company, acting as an expert contributor, strategist, and project manager at the portfolio level.
What You'll Do
- Serve as an expert contributor on the partner's project teams at the portfolio level.
- Write, advise, and coordinate the development of complex clinical regulatory documents.
- Lead the development of key documents that inform and align with project strategy.
- Manage writing projects, coordinate with stakeholders, steer discussions, drive consensus, and facilitate decision-making to propel the document development cycle forward.
What We're Looking For
- An advanced degree (PhD or Masters).
- A minimum of 6 years of eCTD submission writing experience, including 3 years as a medical writing project lead.
- Proven experience and proficiency in writing and leading the development of a variety of clinical regulatory deliverables, with extensive experience leading content development for efficacy or safety clinical summary modules and drug applications across different regions.
- Demonstrated success leading stakeholders and project teams through submission document development.
- Comfort leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing expertise based on experience.
- Readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.
Team & Environment
This role is sponsor-dedicated, embedding you directly on the client's team. Fortrea empowers its team to steer their own development and offers comprehensive training and support to prepare for leadership roles.
Work Mode
This is a fully remote position. Candidates must be based in the UK, Spain, Portugal, or Greece.
Fortrea is an equal opportunity employer.
