Senior Regulatory Medical Writer, Client-embedded, FSP
Core
Senior Medical Writer authoring clinical and preclinical regulatory documents for internal and external clients to ensure operational excellence and compliance.
Role type
Senior IC regulatory medical writer
Builds
Clinical study reports, protocols, Investigational Brochures (IBs), bioassay reports, INDs, and MAAs
Domain
Pharmaceutical/CRO industry, clinical research
Required skills
clinical regulatory document authoring, data interpretation, project management, document structure and presentation design, regulatory guideline knowledge, mentorship
Preferred skills
preclinical regulatory document authoring, pharmaceutical/CRO industry experience, AMWA/EMWA/RAC certifications
Technologies
document management systems, Excel, Outlook
Responsibilities
Author routine clinical documents (CSRs, protocols) and complex regulatory documents (IBs, INDs, MAAs); Collaborate with cross-functional teams to ensure document accuracy; Review and provide feedback on documents prepared by others; Mentor junior medical writers; Manage project timelines and deliverables
Seniority
Senior, hands-on IC
