Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
This position requires an individual in Lilly Research Laboratory (LRL) Operations – Research Integrity and Compliance to provide support and perform the roles of Discovery Biology Submission Coordinator and Quality Reviewer.
This individual will be responsible for:
- Monitoring Candidate Selection and regulatory submission timelines to ensure that preclinical pharmacology summary and individual reports are assigned and scheduled, and that all reporting process roles are properly assigned.
- Providing established training courses, guidance and support to Lead Biologists, Lead Biochemists and research scientists regarding LEO regulatory document processes and submissions.
- Providing critical review of regulatory submission documents generated by Toxicology, Drug Disposition and Biology (e.g., Investigator’s Brochures, INDs, Briefing Documents, Regulatory Responses, etc.).
- This role includes expertise with the LEO document management system and responsibility for ensuring the accuracy and integrity of documents prior to submission to regulatory agencies worldwide.
- In addition, other documents to be quality reviewed include Toxicology and Biology contributions to Candidate Selection documentations and presentations.
- Maintenance and revision of documents describing report submission and quality review process expectations, including report templates.
- Develop expertise in the Quality Review process for Toxicology, Drug Disposition and Biology documents and serve as a primary Quality Review contact.
- Develop and implement continuous improvement of the quality review process including scheduling, organization of needed materials, and quality review of reports.
- Build effective working relationships with Toxicology, Drug Disposition and Biology scientists and management in order to perform and improve the quality review process, including provide education and awareness through communication of findings and metrics.
- BS/BA in Biology, Pharmacology, or another scientific field of study.
- 1+ years of experience within the drug development/discovery process or the pharmaceutical regulatory submission process.
- Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
- Background or experience with Preclinical research and drug discovery, as well as preclinical regulatory reporting guidelines
- Familiarity with Good Research Practices and Good Laboratory Practices regulations
- Discovery biology experience
- Previous quality control/quality review experience
- Familiarity or previous experience with regulatory submission processes
- Ability to interact directly and effectively with Research (Toxicology, Drug Disposition, Biology and Chemistry) management and scientists
- Familiarity or expertise with Microsoft (Excel, Word, PowerPoint)
- Familiarity or expertise with LEO and eCTDXpress reporting systems
- Ability to work independently, set own schedules, and make decisions that impact own priorities and allocation of time to meet deadlines
- Ability to respond to customer requirements and handle standard and non-standard requests from customers
- High learning agility to provide quality review support including thorough review of scientific documents
- Good communication and presentation skills
- Good problem-solving skills
This position is not permanent. It is for a fixed duration for up to 4 years.
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.