Are you looking for a rewarding career in clinical research? Fortrea, a leading global contract research organization, is hiring for two exciting roles: Medical Writer I (Mumbai) and TMF Classifier I (Bangalore). Explore these job opportunities and apply before the deadline!
About Fortrea
Fortrea is a global leader in life sciences and clinical research, offering comprehensive solutions in drug development. The company provides end-to-end support to pharmaceutical, biotechnology, and medical device industries, ensuring regulatory compliance and high-quality research outcomes.
1. Medical Writer I – Mumbai
Job Overview:
The Medical Writer I is responsible for preparing clinical study protocols, clinical study reports (CSRs), and other medical documents. The role requires interpreting clinical, pharmacokinetic, and statistical data while ensuring the timely delivery of high-quality documents.
Key Responsibilities:
- Independently prepare protocols and CSRs for lower complexity studies.
- Collaborate with experienced writers on higher complexity studies.
- Write and review patient safety narratives and CSR appendices.
- Conduct data interpretation and ensure compliance with ICH guidelines.
- Review Statistical Analysis Plans (SAP) and Tables, Figures, and Listings (TFLs).
- Provide training to Associate Medical Writers.
Qualifications & Requirements:
- Bachelor’s degree in life sciences (Master’s/PhD preferred).
- Minimum 1 year of medical writing or 2 years of clinical research experience.
- Strong scientific writing and communication skills.
- Good knowledge of MS Word, medical, and pharmacokinetic principles.
Application Deadline: March 26, 2025 (11 hours left to apply!)
Location: Mumbai
2. TMF Classifier I – Bangalore
Job Overview:
The TMF Classifier I is responsible for managing the document classification in Smart Inbox and ARC review, ensuring electronic Trial Master Files (eTMF) compliance in clinical studies.
Key Responsibilities:
- Manage document classification, review, and deletion in eTMF.
- Perform quality checks on electronic documents for audit readiness.
- Ensure compliance with Good Clinical Practice (GCP) and ICH guidelines.
- Participate in regulatory audits and implement corrective actions.
- Attend internal and external study meetings.
- Improve business processes for better quality and efficiency.
Qualifications & Requirements:
- Bachelor’s Degree in Life Sciences/Business focus (Master’s preferred).
- 6-12 months of experience in a clinical research environment.
- Familiarity with GCP, ICH guidelines, and regulatory documentation.
- Strong skills in Microsoft Office, Adobe Acrobat, and eTMF systems.
Application Deadline: March 28, 2025 (2 days left to apply!)
Location: Bangalore
