FSP Principal Medical Writer (Regulatory) - Client-Dedicated
Core
Lead a dedicated team of medical writers to produce high-quality clinical study reports, protocols, and regulatory documents (IBs, INDs, MAAs) for 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/CRO industry, Regulatory Affairs, Clinical Research
Required skills
Medical writing, Clinical study report authoring, Protocol writing, Regulatory compliance, Project management, Data interpretation, Mentoring, Process improvement
Preferred skills
Neurology, Immunology, Oncology, Vaccines, Submissions document experience, AMWA/EMWA/RAC certifications, Pharmaceutical/CRO industry experience, Neuroscience
Technologies
Document development software
Responsibilities
Research, write, and edit clinical study reports and study protocols; Serve as primary author for complex regulatory documents; Provide senior-level review and mentorship to junior writers; Develop and review best practices and performance metrics; Represent the department at project launch and review meetings.
