Write and edit clinical study reports (CSRs), Investigator’s Brochures (IBs), clinical trial protocols, and informed consent forms.
Develop regulatory documents including CTD summaries (Modules 2.5, 2.7), Risk Management Plans (RMPs), Briefing Documents, and Responses to Health Authorities.
Create medical content for scientific publications, slide decks, medical articles, and patient education materials.
Translate complex medical and scientific data into clear and concise text suitable for regulatory bodies, healthcare professionals, or the public.
Collaborate with cross-functional teams (Regulatory, Clinical, Pharmacovigilance, Marketing).
Conduct thorough literature reviews to support medical writing tasks.
Ensure compliance with ICH, GCP, and regulatory guidelines.
Maintain version control, document tracking, and project timelines.