Senior Medical Writer

Roles & Responsibilities
• Act as a primary Regulatory Medical Writer embedded within a sponsor-dedicated team for a leading global pharmaceutical company
• Lead the end-to-end development cycle of high-complexity Phase II–IV clinical regulatory documents
• Author and project-lead development of Protocols and Clinical Study Reports (CSRs) with minimal supervision
• Drive planning and coordination activities from kick-off through final delivery to the sponsor
• Lead kick-off strategy meetings to align cross-functional and geographically distributed teams
• Conduct communication strategy meetings to consolidate expert input into cohesive Shell Skeleton Reports
• Facilitate comment-resolution meetings to address conflicting feedback early and ensure smooth document development
• Maintain alignment with sponsor goals, timelines, milestones, and critical paths
• Coordinate inputs from functional teams to ensure timely, high-quality document delivery
• Interpret raw clinical study data (efficacy, safety, exposure, endpoints) into clear, concise regulatory language
• Support development of Investigator’s Brochures, Safety Narratives, ICFs, Efficacy Summaries, and regulatory responses
• Ensure compliance with sponsor SOPs, ICH-GCP, and global regulatory requirements

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

Experience
• Minimum 4 years of regulatory medical writing experience
• At least 2 years as a Medical Writing Project Lead
• Extensive experience authoring and leading development of Protocols and CSRs

Skills
• Strong leadership and project-management capabilities in medical writing
• Ability to coordinate and collaborate with cross-functional global teams
• Excellent written and verbal communication skills
• Proven ability to manage complex documents, drive consensus, and facilitate decision-making
• High adaptability across therapeutic areas and client environments
• Proactive, collaborative, and detail-oriented approach

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

About the Organization
Fortrea – A global clinical development and patient access solutions company dedicated to accelerating delivery of life-changing treatments, offering diverse career paths, strong leadership opportunities, and global collaboration in regulatory medical writing.