Senior Associate, Product Information/Claims Support
Core
Senior Associate responsible for product information management, claims support, and regulatory dossier preparation in the pharmaceutical industry.
Role type
Senior Associate, Product Information & Regulatory Support
Builds
Product labeling documents, safety dossiers, and scientific reference materials
Domain
Pharmaceutical / Consumer Healthcare
Required skills
Regulatory compliance, scientific literature analysis, SOP development, GAP analysis, cross-functional collaboration, project management, data sheet maintenance, safety reporting
Preferred skills
Therapeutic area knowledge (Pain, Digestive Health, Smoking Cessation, UR/Allergy), experience with Investigator Initiated Studies (IIS), media issue management
Technologies
QMS, ISMS, PIMS, GDPR
Responsibilities
Develop and coordinate performance improvement projects; maintain Client Core Data Sheets and Core Safety Information; perform compliance checks and compile regulatory dossiers; review source documents and prepare SOPs for global labeling; conduct literature searches and analyze scientific data; create standard language for product information manuals; provide medical support for packaging and labeling; collaborate on copy clearance committees; generate safety reports (PSURs, annual reports); support Investigator Initiated Studies.
Seniority
Senior, hands-on IC