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Lilly looking for Regulatory Editor, B.Pharm, M.Pharm Apply


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Lilly looking for Regulatory Editor

At Lilly, we make a difference for people the world over by discovering, developing and delivering the breakthrough medicines that help them live longer, healthier more active lives. What’s more, you can also count on us and our people to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism and a creative and innovative can-do spirit.

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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