Lilly CMC Regulatory Editor in Bengaluru, India
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 35,000 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.
Primary 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 not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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 with minimum 2 to 4 years of relevant experience.
Other Information/Additional Preferences
eCTD Publishing experience.
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 capabilities
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 help 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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!