✅ Amgen Hiring Associate & Sr Associate Regulatory Writing
🏢 Company: Amgen
📍 Location: Hyderabad, India
🎓 Eligibility: B.Pharm, M.Pharm, M.Sc
🧪 Experience: 1–2 Years
📝 Job Type: Full-Time | Regulatory Writing | Biotech
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
🏢 About Amgen
Amgen, a global biotechnology leader for over 40 years, develops innovative medicines that make a difference for millions of patients worldwide. This is your opportunity to join a company at the forefront of biotech and clinical research.
📄 Associate Regulatory Writing (R-224167)
- Prepare clinical regulatory documents for public disclosure.
- Anonymize personal data and redact confidential information.
- Ensure submission readiness and timely handoffs.
- Support trial disclosure audits and inspections.
- Manage CTRS system access, reports, trackers, and metrics.
📄 Sr Associate Regulatory Writing (R-224172)
- Lead preparation of regulatory documents for public disclosure and registries (e.g., ClinicalTrials.gov).
- Collaborate with cross-functional teams on redaction strategies.
- Ensure submission readiness and compliance with guidelines.
- Support process improvements and trend analysis.
- Administer CTRS and generate reports.
✅ Eligibility & Skills
Associate:- Bachelor’s degree + 1 year experience with regulatory documents and disclosure compliance.
- Bachelor’s degree + 2 years experience preparing clinical regulatory documents for public disclosure.
🎁 Why Join Amgen
- 🌍 Global biotech leader driving medical innovation.
- 📈 Exposure to regulatory writing and clinical trial disclosure.
- 💼 Career growth opportunities in a highly regulated, impactful field.
📌 Note : Select the role that best matches your experience and career goals. You may apply to both if eligible.
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