Company Description Jehangir Clinical Development Centre (JCDC) is a global, clinical-stage full-service Contract Research Organization (CRO) offering end-to-end support for Phase I–IV clinical trials, validation studies, real-world evidence studies, and biobanking projects. The organization has successfully executed more than 350 clinical projects across pharmaceutical, biotechnological, nutraceutical, herbal, medical device, and other therapeutic products. JCDC specializes in medical writing, monitoring and project management, clinical data management, regulatory support, biostatistics, and site management. It is the first and only hospital-based research center that is ISO 9001:2008 certified and accredited by AAHRPP, and has been recognized as the Best Investigator Site by the Indian Society of Clinical Research. JCDC is committed to clinical precision and high-quality research standards.

Role Description The Medical and Regulatory Writing Associate will be responsible for preparing, reviewing, and editing a variety of clinical and regulatory documents, such as protocols,



informed consent forms, clinical study reports, investigator brochures, and regulatory submission dossiers. The role involves interpreting clinical data, ensuring alignment with regulatory requirements, and maintaining consistency with internal templates and style guidelines. The associate will collaborate closely with clinical, regulatory, biostatistics, and data management teams to gather information, clarify technical details, and meet project timelines. Additional responsibilities include maintaining document version control, supporting responses to regulatory queries, and contributing to process improvement for medical writing and documentation practices.

Qualifications
• Robust knowledge of regulatory frameworks, including Regulatory Compliance and Regulatory Requirements for clinical research.
• Experience in Regulatory Affairs and preparing Regulatory Submissions to ethics committees

📌 Medical and Regulatory Writing Associate (Pune)
🏢 Jehangir Clinical Development Centre (JCDC)
📍 Pune