Senior Medical Writer
Core
Leading the development of high-quality regulatory and clinical documents to support clients' submissions to regulatory authorities.
Role type
Senior IC medical writer (regulatory)
Builds
Regulatory submissions (INDs, marketing applications, Clinical study reports, IBs, Protocols)
Domain
Healthcare / Clinical Research / Regulatory Affairs
Required skills
Medical writing, Clinical development knowledge, International regulations (ICH, CTD), Document preparation, Substantive editing, Resource management
Preferred skills
Managing writing activities for major international regulatory submissions, Experience in pharma or biotechnology
Technologies
Electronic documents and submissions systems
Responsibilities
Guide medical writing document preparation and coordinate assignments, Formulate writing approach and develop timelines for key documents, Provide advanced input for study designs and analysis plans, Review and edit contributions to ensure resolution of issues, Represent Medical Writing on cross-functional teams, Act as key Medical Point of contact for clinical regulatory strategy, Serve as lead writer for important regulatory response documents
Seniority
Senior, hands-on IC
