Associate – Clinical Trial Label Regulatory Compliance at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Bachelor's degree in scientific or health science discipline (e.g. pharmacy, nursing, chemistry or related scientific discipline)
3 years industry-related experience in regulatory affairs, CT Labeling and/or drug development
Knowledge of regulatory procedures and practices across regions (FDA, PMDA, etc) and awareness of evolving regulatory reforms and initiatives
Knowledge of drug development process
Demonstrated ability to assess regulations in multiple countries

Responsibilities

Develop and maintain regulatory strategy for CT material labels and CT material regulations (including phrase library)
Propose updates to process and procedures as regulations change to ensure compliance
Provide high quality and timely regulatory advice on CT material labels and CT material regulations to allow business partners to make well-informed decisions
Contribute to impact assessments on evaluation of regulation changes driving solutions that meet needs of the affiliate and the business
Coordinate with CT Label Regulatory Compliance management to manage issues, propose mitigation/response plans to resolve issues and effectively implement action plans for regulatory challenges/issues
Participate in interpretation and implementation of regulations impacting CT material across Clinical Supply and Delivery, Clinical, and Regulatory organizations through proactive and effective communication
Contribute and participate in periodic regulatory reviews of country regulations
Create and participate in change controls when standard processes must be modified or changed
Proactively identify ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk
Stay abreast of cGMPs, GDP’s, GCPs, and other regulatory requirements related to CT material labels and CT material regulations
Additional responsibilities may include: Identify root causes when issues occur and lead the development of recommendations, strategies, communications, and implementation of corrective actions and lessons learned
Effectively plan for upcoming work and communicate to other groups as needed
Collecting and reporting metrics
Involvement with special projects and periodic reviews
Management of Phrase Library activities, as required

Skills

Regulatory Compliance

Clinical Trial Labeling

Global Regulations

Regulatory Strategy

Change Management

Process Improvement

CMC Regulations

Label Phrase Library

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.

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