Torrent Pharmaceuticals is a leading Indian multinational pharmaceutical company known for its high-quality generic and specialty formulations. With a strong presence in domestic and international markets, Torrent Pharma focuses on research-driven drug development and regulatory compliance. The company has a reputation for excellence in bioequivalence (BE) and bioavailability (BA) studies, making it a preferred employer for pharmaceutical professionals.
Job Description: Medical Writer – Bioequivalence Studies
Key Responsibilities:
✔ Feasibility Assessment & New Product Evaluation – Conducting preliminary research for BE study viability.
✔ Literature Review & Study Design – Designing BA/BE study protocols based on scientific literature.
✔ BE Study Monitoring – Overseeing clinical trials and ensuring compliance with regulatory standards.
✔ Regulatory Documentation – Preparing submissions (BENOC, Import License Applications, etc.).
✔ Dossier Preparation – Writing clinical/non-clinical overviews, summary tables, and other submission documents.
✔ Document Review – Ensuring accuracy in BE study protocols, reports, and Informed Consent Forms (ICF).
✔ Medical Writing – Drafting and reviewing scientific content for regulatory filings.
✔ Safety Reporting Coordination – Managing SAE (Serious Adverse Event) reporting to regulatory agencies.
Preferred Candidate Profile
✅ Education: M.Pharm (Pharmacology)
✅ Experience: 1-5 years in bioequivalence/clinical research/regulatory writing
✅ Skills Required:
- Strong understanding of BE/BA studies
- Knowledge of regulatory guidelines (USFDA, EMA, CDSCO)
- Excellent scientific writing & documentation skills
- Ability to analyze clinical data
How to Apply?
Interested candidates can email their CV to:
📧 vilshashah@torrentpharma.com
