Associate Director - Clinical Regulatory ScientistAt 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.
Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory and Scientific Expertise Develop, Update and Execute US and Canada Registration StrategyInitiate and Update Regulatory Strategy DocumentProvide input to clinical program to support market differentiation needs Communicate the regulatory options and impact on proposed product development plans.Leverage innovative regulatory strategies with accompanying required data to accelerate asset development.Support development and update of labeling strategy to deliver market differentiation Initiate and update Claims Mapping and Labeling Dashboard.Develop and Update US and CA labeling Support the development of the US/Canadian labeling strategy in collaboration with project personnel.Minimum Qualification Requirements: Bachelor's degree in scientific or health sciences discipline.Industry-related experience in regulatory affairs and/or drug development for a minimum of 2 years.Knowledge of FDA and Health Canada procedures and practices.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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