Job Description
Vacancy for Analyst GRA at Lilly 2023. 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.
| Organization | Lilly |
| Post Name | Analyst – GRA |
| Job Location | Bangalore, Karnataka |
| Official Website | https://www.lilly.com/ |
Job Title/Position:
Analyst – GRA
Job Overview:
Job vacancy for Pharmacy
Job Location:
Bangalore, Karnataka
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What are the Key Responsibilities?
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
What are the Educational Qualification(s) for Analyst – GRA?
M.Pharm or equivalent degree in a scientific or related field
What is the Age Limit for this post?
Minimum 1 to 2 years of Document Finalisation/Document Editing experience for CMC documents and knowledge of maintaining databases
What are the Preferred Skills required for this Job/Position?
- 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
Related:
- Vacancy for Research Assistant at NITRD 2023
- Vacancy for Publications Writer at Pfizer 2023
- Multiple vacancies at National Institute of Epidemiology 2023
- Vacancy for Trainee at GE Healthcare 2023
- Vacancy for Medical Writer at Syneos Health 2023
- Vacancy for Associate Content Editor at Clarivate 2023
- Vacancy for Pharmacist at National Institute of Sowa Rigpa 2023
Detailed notice
https://careers.lilly.com/us/en/job/LILLUSR54056EXTERNALENUS/Analyst-GRA
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