Parexel

Compensation

Full Description

Job Description: • Drive the labeling development and strategy, in-line with overall global strategy. • Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other). • Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines. • Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds. • Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy. • Support global Health Authority interaction strategy regarding all aspects of labeling. • Collaborate with global colleagues and partners as needed. • Develop clear communications for senior management and labeling stakeholders. Requirements: • BSc or advanced scientific degree (MSc, PhD or PharmD) preferred. • 6-8 years of relevant pharmaceutical Labeling/Regulatory experience. • Thorough understanding of scientific principles and regulatory systems, relevant to drug development. • Experience writing CCDS and local labeling documents for new products. • Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required. • Ability to prioritize and manage multiple high to medium complex projects simultaneously. • Strong attention to detail. • Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite. Benefits: • Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development