Michele Sharp Email & Phone Number

Indiana, United States

Chief of Staff for Global Regulatory Affairs serving as the senior advisor to the Vice President of Global Regulatory Affairs on all matters of business transformation and regulatory excellence. Responsible for driving strategic leadership, implementing business transformation initiatives, and advancing organizational effectiveness with a focus on people.

Indianapolis, Indiana Area

• Lead a team of 20+ Regulatory professionals in the review of Lilly USA advertising and promotional communications for over 20 marketed products
• Advise Lilly leaders and teams on how to navigate FDA laws and regulations and meet business objectives when communicating about Lilly products and disease areas of interest
• Engage with Lilly drug development teams in evaluating the evidence generated from research and development programs to support anticipated product labeling and promotional messages for the future
• Contribute in the development and execution of company standards and procedures that deliver high quality and consistently compliant information about Lilly products
• Collaborate with other Lilly Regulatory leaders to create value for patients by executing regulatory strategies that deliver marketplace differentiation for innovative pharmaceutical products
• Serve as Lilly’s chief spokesperson with the FDA Office of Prescription Drug Promotion for all matters concerning advertising and promotion

Indianapolis, Indiana Area

• Develop regulatory strategy for new indications and additional product presentations of a prescription drug product approved to treat psychiatric illnesses
• Lead development team during interactions with FDA, including meeting preparation, submission of supplemental marketing applications, and negotiation to final approval
• Advise, direct and execute numerous product labeling updates, including coordination with Lilly Regulatory colleagues in affiliates around the world
• Collaborate with development team in preparing response to FDA requests related to product safety assessments and investigator audits
• Provide advice to Lilly USA commercial team on promotional communications and activities for product

• Coordinate with drug development team and Regulatory scientist in creation of proposed labeling for products in development in submission of marketing applications to FDA
• Collaborate with assigned Regulatory scientist to execute updates to FDA approved labeling for US marketed products in neuroscience, diabetes, infectious disease and oncology therapeutic areas
• Develop initial company core data sheets for approved marketed products and facilitate updates as new safety information is obtained
• Support compliance with FDA prescription drug labeling requirements
• Provide drug labeling expertise in leading Lilly to comply with new FDA requirements for pediatric and geriatric use submissions
• Serve as subject matter expert for Lilly labeling processes, including core data sheets, US physician and patient inserts and package labeling components

Indianapolis, Indiana Area

• Provide medical support for approximately 40 non-promoted, marketed products
• Write annual reports, review and analyze spontaneous safety reports, assess labeling changes and answer medical information questions

Indianapolis, Indiana Area

• Verify physician orders, dispense oral and intravenous medications and participate in investigational drug studies
• Answer drug information questions from nurses, physicians and dieticians
• Support patient care teams to cost effectively monitor therapeutic outcomes