Sun Pharma is one of the largest pharmaceutical companies in India, known for its innovation and excellence in healthcare solutions. With a strong global presence, Sun Pharma is committed to improving patient lives through high-quality medicines and cutting-edge research.
Job Description
Key Responsibilities:
- Prepare high-quality clinical trial documents including protocols, investigator brochures, clinical study reports (CSR), and regulatory submissions.
- Conduct literature reviews to support protocol development and manuscript writing.
- Write manuscripts, abstracts, and posters for conferences and publications.
- Ensure compliance with ICH-GCP, FDA, ICMR, and other regulatory guidelines.
- Coordinate with vendors, data management teams, and biostatisticians for timely study deliverables.
- Register clinical trials on platforms like CTRI (Clinical Trials Registry – India).
- Maintain SOPs (Standard Operating Procedures) for medical writing activities.
- Work closely with medical monitors to review study documents (SAP, CRF, DMP).
- Use MedDRA and WHO-DD for adverse event and drug coding.
Desired Skills & Qualifications:
- 0-1 year of experience in medical writing (freshers with strong academic background may apply).
- Excellent scientific writing skills with knowledge of IMRAD & CONSORT guidelines.
- Familiarity with GCP, GDP, and regulatory requirements (ICMR 2017, Drugs & Cosmetic Act).
- Proficiency in Excel and statistical tools.
- Strong communication, teamwork, and analytical skills.
- Ability to work in a fast-paced, matrix environment.
Why Join Sun Pharma?
- Work with a leading global pharmaceutical company.
- Opportunity to contribute to cutting-edge clinical research.
- Career growth in a dynamic and innovative environment.
