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 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.
Overview/Position Summary:
The process of sourcing and supplying Investigational Medicinal Products and commercial drug products for global clinical trials has grown in complexity for the trial sponsor in recent years. The role of the Clinical Trial Label Regulatory Compliance Associate is to participate in maintenance and interpretation of the clinical trial (CT) material label requirements and CT material regulations, including commercial products, working with global regulations to ensure compliant CT material labels and appropriate classification of commercial product.
To accomplish this, it is necessary for the Associate to develop collegial and mutually productive relationships across Lilly affiliates, the Clinical Supply and Delivery organization, external clinical and regulatory vendors, regulatory colleagues in GRA, GOLD, and GRA-CMC and when necessary, within regulatory bodies worldwide. The Associate will utilize regulatory knowledge, CT material knowledge and process expertise to drive consistency and quality in labels and influence effective change management when needed.
Key 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
Basic 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, experience in CT Material regulations preferred
Strong proficiency with computer applications including Outlook and Microsoft Office.
Strong interpersonal skills, including capability to engage in professional relationship building and networking.
Strong written and verbal communication skills.
Ability to manage multiple tasks, excellent attention to detail, strong organization, and self-management skills.
Ability to work in an independent, flexible environment.
Working knowledge of GCP regulations, MQS, and GMP/GDP requirements.
Demonstrated critical thinking and problem-solving skills.
Knowledge of Clinical Trial and Protocol Design
Knowledge of procedural and regulatory requirements
Must speak fluent English
Additional Preferences:
Project management
CT Material Commercial Product sourcing
RPh, PharmD or JD
TrackWise Experience
Additional Information:
Work outside of core hours may be required to support the portfolio across the globe
May require travel domestically and international (less than 10%)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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