Senior Strategic Medical Writer - Remote
Core
Leading and writing clinical and regulatory documents for drug and device development to support company objectives.
Role type
Senior Strategic Medical Writer
Builds
Clinical and regulatory submission materials for AbbVie drugs and devices
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical and regulatory document writing, ICH guidelines, GCP, CONSORT, PRISMA, drug development lifecycle, clinical research study designs, biostatistics, pharmacology, medical terminology, project management, cross-functional collaboration
Preferred skills
EU and US device writing experience
Technologies
ICH guidelines, GCP, CONSORT, PRISMA
Responsibilities
Prepare clinical and regulatory documents for drug/device development; coordinate review, approval, and quality control of clinical projects; develop knowledge of US and international regulations; participate in tactical process improvements; address inquiries and draft responses for inspection readiness
Seniority
Senior, hands-on IC