Senior Medical Writer, Promotional Review
Core
Reviews promotional and non-promotional medical materials for clinical accuracy and FDA compliance; drafts and reviews medical information documents like Standard Response Letters and FAQs.
Role type
Senior Medical Writer (Promotional Review & Medical Information)
Builds
Promotional collateral, Standard Response Letters, FAQs, product dossiers
Domain
Life Sciences / Regulatory Affairs / Medical Writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, clinical data interpretation, regulatory compliance (FDA-OPDP), project management, therapeutic area knowledge, document management systems
Preferred skills
Veeva PromoMats expertise, mentorship of junior writers, strategic rationale for language changes
Technologies
Veeva PromoMats, CRM-based platforms, Excel, Outlook
Responsibilities
Review promotional materials for scientific accuracy and compliance; draft Standard Response Letters and FAQs; mentor junior writers on document preparation and regulatory requirements; develop best practices for document development.
Seniority
Senior, hands-on IC