Job Description

Vacancy for Specialist – Regulatory Editor at Lilly 2023.

Organization	Lilly
Post Name	Specialist / Sr Specialist – Regulatory Editor
Job Location	Bangalore, Karnataka
Official Website	https://www.lilly.com/

Job Title/Position:

Specialist / Sr Specialist – Regulatory Editor

Job vacancy for Pharmacy

Bangalore, Karnataka

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.

B.Pharmacy/M.Pharmacy or equivalent degree in a scientific or related field.

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

Related:

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.