Senior/ Medical Writer
Core
Senior medical writer developing clinical documents (CTRs, Protocols, IBs) for biopharma sponsors, focusing on eye health and inflammation.
Role type
Senior IC medical writer
Builds
Clinical trial reports, protocols, investigator's brochures, and regulatory submission documents
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Medical writing, global regulatory guidelines (ICH, FDA, EMA), clinical research processes, document management systems (eDMS), project management, quality control
Preferred skills
Eye health and inflammation therapeutic areas, advanced degree (MSc, PhD, PharmD, MD)
Technologies
Microsoft Word, Electronic Document Management Systems (eDMS)
Responsibilities
Manage clinical document lifecycles in EDMS, prepare and conduct trial team meetings (kick-off, RAM), write and revise complex clinical documents, perform quality control checks, ensure alignment with sponsor SOPs
Seniority
Senior, hands-on IC
