Principal Medical Writer

Roles & Responsibilities
• Work sponsor-dedicated and embedded within the team of a Top 10 global pharmaceutical company
• Act as an Expert Contributor at portfolio level, providing scientific, regulatory, and strategic medical writing expertise
• Author, advise, and coordinate development of high-complexity clinical regulatory documents
• Lead development of efficacy and safety clinical summaries (CTD Sections 2.73 & 2.74)
• Author and oversee Clinical Study Protocols, Clinical Study Reports (CSRs), and Investigator Brochures
• Provide full document oversight for CTD / eCTD submissions for global regulatory authorities
• Serve as a Strategist, ensuring document content aligns with overall project and submission strategy
• Act as a Project Lead, managing writing activities and coordinating cross-functional stakeholders
• Drive discussions, resolve conflicts, and facilitate decision-making to ensure timely, high-quality deliverables
• Lead stakeholders and project teams through end-to-end submission document development
• Ensure compliance with global regulatory guidelines, sponsor SOPs, and submission standards

Qualification
• Advanced degree (PhD or Master’s) in Life Sciences or related discipline

Experience
• Minimum 6 years of experience in eCTD submission medical writing
• At least 3 years of experience as a Medical Writing Project Lead
• Extensive experience leading content development for efficacy and/or safety clinical summary modules
• Proven experience supporting global drug applications across multiple regions

Skills
• Strong leadership and project management capabilities in regulatory medical writing
• Ability to coordinate, influence, and collaborate with cross-functional global teams
• Excellent written and verbal communication skills
• High level of strategic thinking and scientific judgment
• Proven ability to manage complex documents and drive consensus
• Adaptability across therapeutic areas and client environments

Work Model & Location
• Full-time, permanent role
• Sponsor-dedicated engagement
• Remote / home-based position
• Preferred locations: UK, Spain, Portugal, or Greece

About the Organization
Fortrea – A global clinical development and patient access solutions company empowering medical writers to shape diverse career paths, whether remaining deeply scientific or progressing into leadership, while working with high-profile global pharmaceutical clients.