Medical Writer Job at Fortrea | Life Sciences | Apply Now
Fortrea is looking for a meticulous and detail-oriented Medical Writing Publisher to join its global team in a remote capacity (Hub: Bangalore). This is a specialized Medical Writer Job that moves beyond drafting content and into the high-stakes world of clinical document architecture and regulatory publishing. If you have 2–3 years of experience in managing ICH E3 compliance and Section 16 appendices, this is your chance to build a high-impact Fortrea career. You will be the final gatekeeper for study protocols and Clinical Study Reports (CSRs), ensuring that life-saving data is perfectly formatted for regulatory eyes.
About the Company
Fortrea is a leading global Contract Research Organization (CRO) that emerged as a spin-off from Labcorp’s Clinical Development and Commercialization business. With a mission to bring life-changing therapies to patients faster, Fortrea partners with pharmaceutical and biotech companies to navigate the complex drug development lifecycle.
Key Responsibilities
In this role, your work is the “final polish” that makes scientific data submission-ready. You won’t just be assisting with preparation; you will be managing the technical skeleton of clinical documents.
- Appendices Collation: Take ownership of ICH E3 Section 16 (Appendices). This involves organizing massive amounts of supplemental data into a navigable, compliant format.
- QC & Peer Review: Assist with the rigorous Quality Control (QC) process for Study Protocols, CSRs, and Patient Narratives, catching errors before they reach the sponsor or health authorities.
- Timeline Management: Keep a pulse on project milestones, ensuring Medical Writers and Project Managers are aligned with tight regulatory deadlines.
- Document Publishing: Execute the actual publishing of documents across various departments, ensuring that the electronic versions meet all technical specifications for global filing.
Qualifications & Experience Requirements
Fortrea is looking for a blend of scientific literacy and technical publishing prowess.
- Education: A Bachelor’s degree in Biomedical, Life Sciences, or a related discipline.
- Experience: 2 to 3 years of experience specifically as a Publisher within a medical writing or clinical department.
- Technical Knowledge: Deep familiarity with ICH GCP and regulatory requirements for national and multinational studies.
- Soft Skills: Excellent command of English (written and oral) and the ability to set priorities for complex tasks with minimal supervision.
Transitioning into a Medical Writing Publisher role at Fortrea is a strategic move for professionals who enjoy the technical and organizational side of science. A Fortrea career offers the stability of a world-class CRO with the flexibility of a remote environment. If you have mastered the art of CSR appendices and QC, ensure your application is submitted before the deadline to join this elite global team.
