CMC- Specialist Regulatory Editor Job Vacancy in Eli Lilly Bengaluru, Karnataka – Latest Jobs in Bengaluru, Karnataka

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Company Name : Eli Lilly
Location : Bengaluru, Karnataka
Position : CMC- Specialist Regulatory Editor

Job Description : 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.
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.
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
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
Perform document management services:
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
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
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
Minimum Qualification Requirements:
M. Pharm or equivalent degree in a scientific or related field
Minimum 2 to 4 years of Document Finalisation/Document Editing experience for CMC documents and knowledge of maintaining databases
RIM knowledge will be preferred.
Other Information/Additional Preferences:
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
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.

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