Key Responsibilities
Conduct comprehensive literature reviews to support the development of clinical study documents.
Draft and review Phase I, II, III, and IV clinical study protocols for drugs, vaccines, and other clinical research projects.
Prepare and maintain study-related documents including:
Study Protocols
Informed Consent Forms (ICFs)
Investigator's Brochures (IBs)
Case Report Forms (CRFs)
Patient Information Sheets
Study Manuals and other essential documents
Prepare protocol amendments and update study documentation as required.
Coordinate with cross-functional teams including Clinical Operations, Pharmacokinetics, Biostatistics, Data Management, Quality Assurance, Regulatory Affairs, Investigators, Sponsors, and Project Management teams to obtain inputs and finalize study documents.
Organize and participate in protocol review meetings.
Support Clinical Data Management in CRF design and review.
Prepare scientific abstracts, manuscripts, presentations,



posters, and slide decks for conferences and scientific meetings.
Ensure all documents comply with ICH-GCP, CDSCO, WHO, applicable regulatory guidelines, and sponsor requirements.
Maintain document quality, consistency, version control, and timely delivery.

Qualifications
Postgraduate in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field.
Relevant experience in Medical Writing within a CRO / BA/BE study centre, pharmaceutical, or clinical research environment preferred.

Skills Required
Solid scientific writing and literature review skills.
Valuable understanding of clinical research and ICH-GCP guidelines.
Proficiency in Microsoft Office.
Excellent written and verbal communication.
Robust attention to detail, time management, and teamwork.

📌 Medical Writer New Delhi
🏢 Insignia Clinical Services
📍 New Delhi