Lifelancer Hiring for Medical Coder
Lifelancer Hiring for Medical Writer
🌟 Position: Medical Writer
📍 Location: Hinjewadi Phase 3, Pune
🎓 Qualifications:
B-Pharm or M-Pharm with clinical experience
Relevant background in Clinical Research
📅 Experience:
2-5 years in Bioequivalence/Bioavailability (BA/BE) studies – Mandatory
Job Responsibilities 📄
1. 📝 Preparation of Protocols:
Develop BA/BE study protocols in accordance with ICH-GCP guidelines for regulatory submissions.
Prepare clinical trial protocols (Phase III / Phase IV) for various regulatory bodies (DCGI, USFDA, EMA, ANVISA, CDSCO, TGA, Canada).
2. 📚 Documentation:
Create and manage investigator brochures, feasibility studies, and study synopsis.
Draft informed consent forms (ICFs) and case report forms (CRFs) based on protocol and study design.
3.🔄 Protocol Amendments:
Prepare protocol amendments, amendment reports, and document lists of changes.
Update any molecule-specific and subject safety-related modifications based on recent literature.
4.🧑⚕️ Clinical Study Reports (CSRs):
Develop CSRs aligned with ICH-GCP for various regulatory submissions (DCGI, USFDA, EMA, ANVISA, CDSCO, TGA, Canada).
5.📊 Regulatory Summaries:
Compile clinical and non-clinical overviews for regulatory submission.
Create and review DBE summary tables for regulatory compliance.
6.🔍 Review & Quality Assurance:
Oversee outsourced documents, including BA/BE study protocols, ICFs, and CSRs, to ensure alignment with company standards.
🌐 Why Join Us?
Work on high-impact projects that contribute to global health and wellness.
Join a dynamic team in a fast-paced, collaborative environment.
Be part of meaningful projects that support patient safety and regulatory compliance.
👉 How to Apply:
Visit Lifelancer for an efficient application process. Lifelancer is a specialized talent-hiring platform connecting experts in life sciences, pharma, biotech, health sciences, healthtech, data science, and IT domains with top industry roles. Apply now for faster responses and a chance to grow your career in medical writing with us!
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