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Post : Specialist / Sr Specialist - Regulatory Editor
Job Description
• Ensure timely delivery of error-free, high-quality CMC documents that meet international standards of written English by :
• Correcting errors in grammar, style, and syntax. Ensuring accuracy of the data and content presented by cross checking with the source documents. Identifying and fixing flaws in logic and flow
• Following style guides/templates provided by the team
• Following best-practice based on Lilly internal standards
• Database update & maintenance. Perform document management services:
• Launching shells and managing document metadata
• Creating and Managing document libraries
• Scheduling documents for quality checks, finalization, and publishing
• Formatting and Editing documents to meet Lilly standards
• Collecting necessary forms, submitting documents to specified venues, maintaining documentation
• Perform document finalization/publishing services:
• Review and format Word files to ensure as many compliance requirements are in the source file as possible.
• Render the Word files into PDFs.
• Preparing final eCTD-compliant PDFs of CMC regulatory documents using publishing software.
• Review the PDFs and edit them as needed to ensure that all regulatory requirements are met eCTD Publishing.
• Publish eCTD submissions as needed.
Candidate Profile
• B.Pharmacy/M.Pharmacy or equivalent degree in a scientific or related field.
• 3-5 Years of relevant experience
• eCTD Publishing experience.
• RIMS Experience
• Basic knowledge of CMC (preferred)
• Excellent MS Word and Adobe PDF skills
• Demonstrated team work skills and effectiveness in the areas of influence, leadership, and conflict resolution
• Experience in the pharmaceutical industry preferred
• High level of attention to detail and superior English-language skills
• Literature reviewing and evaluation capability.
• Ability to multi-task and work under tight timelines
• Proficient with Microsoft Word, PowerPoint, Excel, and Desktop Publishing Software
Additional Information
Experience : 3-5 Years
Qualification : B.Pharmacy/M.Pharmacy
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 30th December, 2023
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