Reliance Life Sciences is a leading biopharmaceutical company committed to innovation in drug development, biosimilars, and clinical research. As part of the Reliance Group, we focus on cutting-edge therapies in oncology, neurology, and rare diseases, with a strong emphasis on regulatory compliance and global submissions.
Detailed Job Description
Role: Lead Medical Writer – Clinical Research
Location: Navi Mumbai
Department: Clinical Research
Experience: 5+ years
Key Responsibilities:
✔ Author high-impact clinical documents (protocols, CSRs, IBs, regulatory submissions) for Phase I–IV trials.
✔ Interpret complex clinical data and translate into clear, compliant documentation.
✔ Collaborate with cross-functional teams (medical, regulatory, biostatistics) to ensure accuracy.
✔ Stay updated with global regulatory guidelines (ICH-GCP, FDA, EMA).
✔ Drive timely submissions for global and local regulatory approvals.
Eligibility & Skills
Must-Have Qualifications:
- Educational Background: Master’s/PhD in Life Sciences, Medicine, Pharmacy, or Biotechnology.
- Experience: 5+ years in medical writing (pharma/biotech preferred).
- Therapeutic Expertise: Oncology, Neurology, Rare Diseases, or related fields.
- Technical Skills: Proficiency in regulatory writing (protocols, CSRs, safety reports).
Preferred Skills:
- Strong scientific writing & data interpretation abilities.
- Familiarity with CDISC standards and eCTD submissions.
- Team leadership & project management experience.
Benefits & Growth Opportunities
✅ Competitive salary & performance incentives.
✅ Work on global clinical trials with industry experts.
✅ Career growth in a leading biopharma organization.
✅ Inclusive workplace encouraging women professionals.
How to Apply
📩 Email your resume to: Pradnya.kadu@relbio.com
📌 Subject Line: “Application for Lead Medical Writer – Clinical Research”
