1. Medical Writer II – Mumbai
Key Responsibilities:
- Lead the preparation of clinical study protocols, clinical study reports (CSRs), and other clinical documents.
- Interpret clinical, pharmacokinetic, pharmacodynamic, and statistical data.
- Develop scientific publications (abstracts, posters, manuscripts).
- Oversee CSR appendices compilation and patient safety narratives.
- Ensure timely delivery of high-quality documents to clients.
- Provide training to junior medical writers.
- Maintain strong relationships with internal and external stakeholders.
Skills Required:
- Strong scientific writing & regulatory documentation skills.
- Knowledge of ICH-GCP, clinical research, and biostatistics.
- Proficiency in Microsoft Office, document management systems.
2. Senior Regulatory Operations Specialist I – Pune (Hybrid)
Key Responsibilities:
- Prepare, compile, and review CMC (Chemistry, Manufacturing, Controls) & regulatory documents for global submissions.
- Manage change control, OOS (Out of Specification), OOT (Out of Trend) investigations.
- Support global labeling, stability data evaluation, and dissolution profile reports.
- Conduct literature surveys for APIs, excipients, and drug products.
- Ensure compliance with regulatory guidelines (USFDA, EMA, WHO, etc.).
- Perform Computerized System Validation (CSV) and software upgrades.
Skills Required:
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- Strong knowledge of regulatory affairs, GMP, and compliance.
- Experience in regulatory submissions (ANDAs, NDAs, DMFs).
- Proficiency in regulatory databases and document management systems.
About the Company
Fortrea leading global pharmaceutical & clinical research organization, known for innovation in drug development and regulatory compliance. Offers a dynamic work environment with opportunities for career growth in medical writing, regulatory affairs, and clinical research.
Eligibility Criteria
For Medical Writer II:
- Education: Master’s/PhD in Life Sciences, Pharmacy, Medicine, or related field.
- Experience: 3-5 years in medical writing, clinical research, or regulatory documentation.
- Salary: ₹8-15 LPA (Based on experience).
For Senior Regulatory Operations Specialist I:
- Education: B.Pharm/M.Pharm, MSc in Pharmaceutical Sciences, Regulatory Affairs.
- Experience: 4-7 years in regulatory operations, CMC, or compliance.
- Salary: ₹10-18 LPA (Based on experience).
How to Apply?
- Medical Writer II (Mumbai): Apply Here (Job ID: 252243)
- Senior Regulatory Ops Specialist I (Pune): Apply Here (Job ID: 251926)
- Last Date: May 16, 2025 (Medical Writer) / May 10, 2025 (Regulatory Ops)
