FSP Principal Medical Writer (Regulatory) - Client-Dedicated
Core
Lead medical writer providing high-quality scientific writing, planning, coordination, and delivery of clinical study reports, protocols, and regulatory documents (IBs, INDs, MAAs) for internal and external clients in the pharmaceutical/CRO industry.
Role type
Principal Medical Writer (Regulatory)
Builds
Clinical study reports, study protocols, Investigational Brochures (IBs), Investigational New Drug applications (INDs), Marketing Authorization Applications (MAAs)
Domain
Pharmaceutical / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study report writing, protocol writing, regulatory document development, data interpretation, project management, mentorship, process improvement, quality compliance
Preferred skills
Neurology, Immunology, Oncology, Vaccines therapeutic areas, Submissions document experience, Neurosciences, AMWA/EMWA/RAC certifications, Pharmaceutical/CRO industry experience
Technologies
Document development software
Responsibilities
Research, write, and edit clinical study reports and study protocols; Serve as primary author for complex clinical and scientific documents; Provide senior-level review and mentorship to junior team members; Develop and review best practices and performance metrics; Represent the department at project launch and review meetings
