Senior Medical Writer
Core
Principal Medical Writer serving as primary author for clinical study reports, study protocols, and data summaries for internal and external clients.
Role type
Principal Medical Writer (Regulatory)
Builds
Clinical study reports, study protocols, and regulatory documents
Domain
Pharmaceutical/CRO industry, Regulatory Medical Writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory medical writing, clinical study report authoring, study protocol development, data interpretation, document development strategy, therapeutic area expertise, project management, mentoring junior staff
Preferred skills
pharmaceutical/CRO industry experience, AMWA/EMWA/RAC qualifications, preclinical/submissions/communications expertise
Technologies
None explicitly stated
Responsibilities
Write and provide input on routine documents such as clinical study reports and study protocols; review documents for the team and provide training and guidance to junior team members; provide advice on document development strategy, regulations and industry best practices; act as backup program manager; collaborate with internal and external clients
Seniority
Principal, hands-on IC with mentorship
