Advertisement
Fortrea is a leading global contract research organization (CRO) committed to delivering life-changing therapies through innovative clinical trial solutions. With a strong focus on biopharma and medical research, Fortrea provides end-to-end clinical development services, ensuring high-quality, regulatory-compliant documentation.
Join a team of experts in clinical research and contribute to groundbreaking medical advancements while working in a flexible, remote-friendly environment.
Detailed Job Description
Job Title: Medical Writer I-CDS
Location: Remote (Mumbai-based)
Job Type: Full-time
Application Deadline: July 10, 2025
Requisition ID: 253711
Advertisement
Key Responsibilities:
- Independently prepare clinical study protocols (CSPs) and clinical study reports (CSRs) for lower-complexity studies.
- Support senior writers in developing higher-complexity documents (protocols, CSRs, regulatory submissions).
- Interpret clinical, pharmacokinetic, and statistical data for accurate documentation.
- Prepare and review patient safety narratives and CSR appendices.
- Ensure compliance with Fortrea/Client SOPs, ICH guidelines, and regulatory standards.
- Review Statistical Analysis Plans (SAPs) and Tables, Figures, Listings (TFLs) for data accuracy.
- Collaborate with internal/external stakeholders to meet project deadlines.
- Train and mentor Associate Medical Writers.
Preferred Skills:
- Strong scientific writing and data interpretation abilities.
- Proficiency in MS Word and regulatory documentation.
- Excellent communication, organization, and project management skills.
Eligibility & Qualifications
Minimum Requirements:
- Bachelor’s degree in Life Sciences (or equivalent).
- 1+ years of medical writing experience OR 2+ years in a related field.
- Advanced degree (Masters/PhD) preferred.
- Fluency in English (written & spoken).
Desirable Experience:
- Background in clinical research, biopharma, or CROs.
- Familiarity with pharmacokinetics, pharmacodynamics, and biostatistics.
Benefits & Work Environment
- Remote work flexibility (based in Mumbai).
- Competitive salary & growth opportunities.
- Exposure to global clinical research projects.
- Inclusive & collaborative workplace culture.
How to Apply
✅ Deadline: July 10, 2025 (10 hours left!)
Advertisement
