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Specialist-GRA

Bengaluru, India

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Req ID R-4479 Title Specialist-GRA City Bangalore State / Province Karnataka Country 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 39,000 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.

Editor and Finalizer for CMC Regulatory Submission :

The purpose of the Chemistry, Manufacturing, and Control (CMC) Editor role is 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 their tasks.

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

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

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-4479.

Lilly is an EEO/Affirmative Action Employer and 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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