Senior Medical Writer
Core
Principal Medical Writer serving as primary author for clinical study reports, study protocols, and data summaries.
Role type
Principal Medical Writer (Regulatory)
Builds
Clinical study reports, study protocols, and regulatory documents for internal and external clients.
Domain
Pharmaceutical/CRO industry, Regulatory Medical Writing
Required skills
Regulatory medical writing, clinical study reporting, protocol development, data interpretation, project management, therapeutic area expertise, document development strategy, mentoring
Preferred skills
Pharmaceutical/CRO industry experience, AMWA/EMWA/RAC qualifications, preclinical/therapeutic/submissions knowledge
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, lead writer with mentorship responsibilities
