Regulatory Specialist

Regulatory Specialist

Handles adverse event reports from scientific literature by collecting, reviewing, and entering global adverse events reports; routes applicable literature on adverse event cases to the appropriate clinical safety physician for review. Provides support to global personnel regarding Global Product Safety policies, processes and procedures by updating SOPs, training tools/programs as necessary. Ensures regulatory compliance for expedited submission of case reports to regulatory authorities. Collaborates with internal and external customers to prepare quality periodic/annual safety summary reports; partners with Global Product Safety physicians to maintain and communicate product safety profile analyses to appropriate persons and groups (e. g., regulatory agencies).

Lilly is an EEO/Affirmative Action Employer and 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. Being on a temporary contractor assignment at Lilly means working in an innovative culture where you have the opportunity to support the work of thousands of others around the globe dedicated to improving the lives of others. Lilly discovers and brings life-changing medicines to those who need them, improves the understanding and management of disease, and gives back to communities through philanthropy and volunteerism. Eli Lilly passionately promotes food security and fosters the human-animal bond to enrich the lives of its customers and the customers they serve as well. Our values: integrity, excellence, respect for people. Greater than 90% of workers rate their Lilly assignment as above average or excellent.

Comments/Special Instructions Candidate does not need to reside in Indiana. Candidate must have some (6m-1year) eCTD publishing experience at a minimum.