Job Description
Vacancy for Analyst 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 |
Official Website | https://www.lilly.com/ |
Job Title/Position:
Analyst – GRA
Job Overview:
Job vacancy for Pharmacy
Job Location:
Bangalore, Karnataka
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
- 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
- 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?
M. Pharm or equivalent degree in a scientific or related field
What is the Experience Required for this Job?
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 Associate at Baxter 2023
- Vacancy for Regional Business Manager at Zydus 2023
- Vacancy for Regulatory Affairs at Roche 2023
- Vacancy for Clinical Data Svs New Associate at Accenture 2023
- Vacancy for Scientist at Sandoz 2023
- Vacancy for Laboratory Assistant at BITS 2023
- Vacancy for JRF at Defence Research Laboratory 2023
- Vacancy for Senior Medical Writer at GSK 2023
Detailed notice
https://careers.lilly.com/us/en/job/LILLUSR52202EXTERNALENUS/Analyst-GRA
You can check Labmonk scholarship for scholarship information.
Check out and answer Labmonk’s daily quiz.
You can read other career related articles on Labmonk Blog. Search Labmonk Blog on google and click the first link for more articles.