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 II (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 II – Mumbai
Job Overview:
The Medical Writer II 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).
- 3 years of experience.
- Strong scientific writing and communication skills.
- Good knowledge of MS Word, medical, and pharmacokinetic principles.
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.
Location: Bangalore
How to Apply for Fortrea Jobs?
Application Link For Medical Writer 2
Application Link For TMF Classifier I
