Opening in Parexel as Senior Associate

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Posts: Senior Associate

Job Description:
Essential Function
• Revise CCDS and supporting documentation, submit to team for review.
• QC labeling documents and artwork
• Proofread artwork
• Consolidate pertinent local regulatory requirements
• Coordinating internal label approval and review process
• Preparation of labeling documentation and submissions
• Preparation of the artwork and submission
• Preparation of the SPL file and submission
• Manage translation activities and assess back translations
• Preparation of the labelling part of the annual report, PBRER and other aggregate reports
• Run global labelling meeting
• Be able to manage activities, coordination and assignment of deliverables