Medical Writer

Insignia Clinical Services; New Delhi; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Insignia Clinical Services in India is seeking a Medical Writing professional to support the development of clinical study documents across multiple phases. You will conduct literature reviews, draft protocols, and prepare essential documents with strict adherence to regulatory guidelines.

The role requires postgraduate life sciences or related field, strong scientific writing, and excellent attention to detail.

Qualifications

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

Responsibilities

• Conduct literature reviews to support development of clinical study documents.
• Draft and review Phase I–IV clinical study protocols for drugs, vaccines, and other projects.
• Prepare and maintain study-related documents including: Study Protocols, ICFs, IBs, CRFs, Patient Information Sheets, Study Manuals.
• Prepare protocol amendments and update study documentation as required.
• Coordinate with cross-functional 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 abstracts, manuscripts, presentations, posters, and slide decks for conferences and meetings.
• Ensure all documents comply with ICH-GCP, CDSCO, WHO, and sponsor requirements.
• Maintain document quality, version control, and timely delivery.

Skills

Scientific writing

ICH-GCP knowledge

MS Office

Communication

Attention to detail

Education

Postgraduate degree in life sciences/clinical research

Job description

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.
• Strong attention to detail, time management, and teamwork.