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Post : Analyst - GRA
The purpose of the Chemistry, Manufacturing, and Control (CMC) Editors and Finalizers role is to use their understanding of the subject matter, the CMC industry, and publication norms to convert complex scientific content into error-free, publication‑ready documents that are both scientifically and linguistically accurate. The CMC Regulatory team at Eli Lilly and Company specializes in providing scientifically rigorous CMC writing services of our CMC data for regulatory submission documents. CMC editors need to network cross-functionally with the GRA-CMC Scientists and Associates, as well as the CMC team members for executing the tasks.
Job Description
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities
Ensure timely delivery of error-free, high-quality CMC documents that meet international standards of written English:
• 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
Perform document management services
• Launching shells and managing document metadata
• Creating and Managing document libraries
• Scheduling documents for quality checks, finalization, and publishing
• Formatting 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
• Review the PDFs and edit them as needed to ensure that all regulatory requirements are met
• Produce final eCTD-compliant PDFs of CMC regulatory documents using publishing software
Candidate Profile
• M.Pharm or equivalent degree in a scientific or related field
• Minimum 1 to 2 years of Document Finalisation/Document Editing experience for CMC documents and knowledge of maintaining databases
• RIM knowledge will be preferred.
• Excellent MS Word and Adobe PDF skills
• Demonstrated teamwork 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
• Basic knowledge of CMC (preferred)
• Literature reviewing and evaluation capabilities
• Ability to multi-task and work under tight timelines
• Proficient with Microsoft Word, PowerPoint, Excel, desktop publishing software
Additional Information
Experience : 1 to 2 years
Qualification : M.Pharm or equivalent degree
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 30th September, 2023
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