Lilly Pharma Regulatory Editor Job – Apply Online
Specialist/Sr Specialist – Regulatory Editor
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time Regular
Job Id: R-57305
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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.
Minimum Qualification Requirements:
- B.Pharmacy/M.Pharmacy or equivalent degree in a scientific or related field.
Other Information/Additional Preferences:
- 3-5 Years of relevant experience.
- eCTD Publishing experience.
- RIMS Experience.
- Basic knowledge of CMC (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.
- Literature reviewing and evaluation capability.
- Ability to multi-task and work under tight timelines.
- Proficient with Microsoft Word, PowerPoint, Excel, and Desktop Publishing Software.
Eli Lilly and Company, Lilly USA, LLC, and our wholly-owned subsidiaries (collectively “Lilly”) are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ([email protected]) for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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