Location: Pune (Hybrid) & Mumbai (Remote)
Job Type: Full-time
Application Deadline: April 1, 2025
Fortrea, a leading global contract research organization (CRO), is hiring for Regulatory Operations Associate I (Pune) and Medical Writer II (Mumbai). If you’re looking for exciting opportunities in regulatory affairs or medical writing, apply now before the deadline!
1. Job Opening: Regulatory Operations Associate I
Job Location: Pune (Hybrid)
Job ID: 251684
Key Responsibilities:
- Prepare, compile, and review CMC (Chemistry, Manufacturing, and Controls) and regulatory documents for global submissions.
- Create and revise raw material & packaging specifications and related documents.
- Coordinate with cross-functional teams for change control, OOS (Out of Specification), and OOT (Out of Trend) evaluations.
- Support financial data management, business plan maintenance, and supplier data management.
- Assist in global labeling documentation, QC activities, and stability data evaluation.
- Conduct literature surveys for APIs, excipients, and drug products.
- Ensure compliance with regulatory guidelines (ICH, FDA, EMA, etc.) for product registrations.
- Perform Computerized System Validation (CSV) and software upgrades.
Qualifications & Skills:
- Bachelor’s/Master’s in Pharmacy, Chemistry, or Life Sciences.
- Experience in regulatory affairs, CMC documentation, or quality assurance.
- Knowledge of GMP, ICH guidelines, and global regulatory requirements.
- Strong analytical, organizational, and communication skills.
2. Job Opening: Medical Writer II
Job Location: Mumbai (Remote)
Job ID: 25812
Job Overview:
The Medical Writer II will lead the preparation of clinical study protocols, clinical study reports (CSRs), and scientific publications (abstracts, posters, manuscripts).
Key Responsibilities:
- Write and review protocols, CSRs, and patient safety narratives.
- Interpret clinical, pharmacokinetic, and statistical data for regulatory submissions.
- Coordinate CSR appendices compilation and narrative projects.
- Ensure compliance with ICH, FDA, and client-specific guidelines.
- Review Statistical Analysis Plans (SAP) and Tables/Figures/Listings (TFLs).
- Mentor junior medical writers and provide training.
- Represent the department in audits and cross-functional meetings.
Qualifications & Skills:
- Advanced degree in Life Sciences, Pharmacy, or Medicine (MD, PhD, MSc).
- 3+ years of experience in medical writing for clinical research.
- Strong knowledge of ICH-GCP, clinical trial documentation, and regulatory guidelines.
- Excellent scientific writing, project management, and communication skills.
About Fortrea
Fortrea is a global Contract Research Organization (CRO) providing clinical trial solutions to pharmaceutical, biotechnology, and medical device companies. With a focus on innovation, compliance, and patient safety, Fortrea supports drug development from Phase I to Phase IV.
Why Join Fortrea?
✅ Hybrid/Remote Work Options
✅ Global Exposure in regulatory and clinical research
✅ Career Growth & Training opportunities
✅ Competitive Salary & Benefits
How to Apply?
🔹 Regulatory Operations Associate I (Pune) – Apply Here
🔹 Medical Writer II (Mumbai – Remote) – Apply Here
(Only 7 hours left!)
