Senior Medical Writer
Core
Leading the development of high-quality regulatory and clinical documents to support clients' submissions to regulatory authorities.
Role type
Principal Medical Writer
Builds
Regulatory submissions and clinical study reports for pharma/biotech clients
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical development lifecycle knowledge, International regulatory guidelines (ICH/CTD), Document preparation and editing, Resource management, Cross-functional collaboration, Strategic writing approach
Preferred skills
Managing writing activities for major international regulatory submissions, Experience with study designs and analysis plans
Technologies
Electronic document systems
Responsibilities
Guide medical writing document preparation and coordinate assignments, Formulate writing approach and develop timelines for key documents, Provide review and substantive editing of contributions, 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
Principal, expert level with minimal supervision
