Intern - GRA at Eli Lilly and Company

Bengaluru, Karnataka, India

Apply Now

Not SpecifiedCompensation

InternshipExperience Level

InternshipJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

High level of technical and practical proficiency with eCTD XPress, Adobe Acrobat, Submission Validation software (Lorenz), ISIToolbox
Successfully complete the formal training modules
Stay up to date on system and tool upgrades that impact publishing
Understand changes to Regulatory Guidance and Requirements
Keep current on latest quality improvement methods

Responsibilities

Plan submission workload by reviewing/monitoring RIM for planned documents for registration submissions
Partner with the Global Regulatory Associate and Regional Submission Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) and/or non-eCTD submissions according to the master table of contents or Content Plan for the dossier
Coordinate global registration activities and provide the necessary documentation to affiliates for registration of products in global countries
Submit and archive submitted submissions, assuring all metadata fields are complete in RIM
Manage FDA Web trader account to enable submissions via electronic gateway
Assure all appropriate metadata fields are completed when archiving in electronic filing system (RIM)
Assure accurate entry for future retrieval of submissions if/when requested
Share technical information among staff members and apply what is learned in day-to-day work
Apply learning from quality review of submission work
Keep up to date in subject matter expert area
Build technical and quality expertise
Advise RDE Management as to potential impact of changes to Regulatory Guidance and Requirements on Publishing
Ensure best practices through partnership with Regulatory Quality

Skills

RIM

eCTD

electronic submissions

FDA Web Trader

eCTD XPress

Adobe Acrobat

Lorenz

ISIToolbox

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

Land your dream remote job 3x faster with AI

Try Jobo Free