Medical Writer – Scientific and Regulatory Documents
Core
Translate complex medical, clinical, and scientific information into clear, accurate, and well-structured documents for healthcare professionals, researchers, and regulatory authorities.
Role type
Medical Writer (Scientific and Regulatory Documents)
Builds
Clinical study protocols, reports, investigator brochures, informed consent forms, regulatory submission materials, and scientific summaries.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Scientific writing, medical terminology, clinical data interpretation, regulatory compliance (ICH-GCP), literature research, reference management, quality control reviews, document structuring, stakeholder collaboration.
Preferred skills
Advanced degree (Masters/PhD/PharmD/MBBS), medical writing certification, ICH-GCP training.
Technologies
Reference management software, scientific databases.
Responsibilities
Draft and edit scientific and regulatory documents; develop clinical study protocols and reports; prepare regulatory submission materials; interpret clinical data and statistical results; conduct literature searches and verify citations; ensure compliance with ICH guidelines and GCP; manage document version control and traceability.
Seniority
Mid-level to Senior, hands-on IC
