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

- Strong scientific writing and literature review skills.
- Good 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