Consulting jobs at PAREXEL help our client companies get and keep biopharmaceutical and medical devices on the market. Through integrated product development services, you’ll help clients maximize their product portfolio value and protect them from regulatory risk. Are you experienced in Early Stage Development, Clinical Trial Regulatory Services, Late Stage Development and Strategic GxP Compliance? Explore Consulting jobs at PAREXEL.
Job ID : 37886BR
Job Description:
• 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
Qualifications
- Post Graduation in Life Sciences/Pharmaceutical sciences.
- Relevant experience in the range of 5-8 years.