Medical Writer

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.