Senior Associate, Trial Disclosure
Core
Provides writing support for clinical trial registration and results postings, including scientific study results and lay summaries, while managing regulatory compliance and document redaction.
Role type
Senior Associate, Medical Writer (Clinical Trial Disclosure)
Builds
Clinical trial registration entries and public disclosure documents for regulatory agencies
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, regulatory compliance, project management, cross-functional communication, data redaction/anonymization, scientific content interpretation, deadline management
Preferred skills
AMWA certification, pharmaceutical editing/writing specialty, international environment experience
Technologies
Excel, Word, global registry systems
Responsibilities
Write scientific study results and lay summaries for global registries; coordinate review and approval of clinical trial registration postings; support agency disclosure activities; redact confidential information in clinical documents; develop and implement SOPs for regulatory processes; manage writing projects to meet timelines and quality standards
Seniority
Mid-level, hands-on IC