Senior Medical Writer (Remote, India| 1pm to 10pm IST shift)
Core
Lead authoring of clinical development documents and regulatory submissions for pharmaceutical and biotech clients.
Role type
Senior Medical Writer (Project Lead)
Builds
Clinical protocols, investigator's brochures, clinical study reports, integrated safety summaries, and regulatory submission modules.
Domain
Pharmaceutical / Biotech / Medical Devices
Required skills
Clinical medical writing, regulatory writing, project management, team leadership, clinical data interpretation, ICH/GCP guidelines knowledge, document management systems
Preferred skills
IND/NDA/MAA submission experience, medical journal publication experience
Technologies
MS Word, Excel, PowerPoint, Document Management Systems
Responsibilities
Author clinical protocols, investigator's brochures, and clinical study reports; manage full project lifecycles and client interactions; mentor junior writers; interpret clinical/scientific data; mitigate project risks.
Seniority
Senior, hands-on IC with leadership responsibilities
