Associate – Clinical Trial Label Regulatory Compliance

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