Indiana Healthcare Jobs

Mobile Indiana Career Connect Logo

Job Information

Eli Lilly and Company Medical Advisor-Medical Affairs-Diabetes - R-11439 in Indianapolis, Indiana

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 39,000 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. Were looking for people who are determined to make life better for people around the world.Clinical Research Physician (CRP) Diabetes Business UnitPurpose:Throughtheapplication of scientificand medicaltraining, clinical expertise, and relevantclinicalexperience, theDiabetes Business Unit-Medical AffairsClinical Research Physician (CRP)is an integral member ofthe medical affairs, development orabusiness unitbrand team for strategic planning in the support of launch and commercialization activities tomeet patients needs andultimately enhance the customers experience in interacting with the company. The definition of customer here includes patients, providers (HCPs) and payers.The CRP may also work closely withglobal Development teams,Therapeutic AreaProgram Phase, Early Phase/ Clinical Pharmacology, and Translational Medicineteams in new product development activities over the entire spectrum ofdrug development andclinical trial phases.Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility,the development, conduct and reporting of localclinical trials; the implementation of global clinical trials conducted inlocal affiliates/countries; the reporting of adverse events as mandated bycorporate patient safety; review process for protocols, study reports, publications and data dissemination for products;new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grantsubmissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from theDirector-Medical and Business Unit Team Physician/Regional Medical Leader, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respectivebusinessunit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase /Clinical Pharmacology, and Translational Medicineteam(s).TheClinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.The Clinical Research Physician is aware of and ensures that all activities of the medical team(and direct reports, if applicable)are in compliance withcurrentlocal and international regulations, laws, guidance (for example, FDA,ICH, andCPMPetc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.PrimaryResponsibilities:The primary responsibility of theDiabetes Business Unit-Medical AffairsCRP is to provide expert medical support to all aspects of the local business, to ultimately enhance the customers experience in interacting with the company.This includes local marketed product support (participate in the development of the patient journey and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for pricing, reimbursement and access(PRA)(providing medical guidance on the PRA plan and interacting with government PRA agencies as nee