Innovation Readiness Clinical Research Scientist
Il y a 3 mois
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.
- Medical Affairs Clinical Research Scientist (CRS) or Clinical Research Physician (CRP) is an integral member of the medical affairs, development or a business unit brand team for strategic planning in the support of launch and commercialization activities to meet patients' needs and ultimately enhance the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs) and payers. The CRS OR CRP may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical 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 local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate 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), grant submissions 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 the Director-Medical and Business Unit Team Scientist/Regional Medical Leader, the CRS OR CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine team(s).
The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), 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.
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.
The primary responsibility of the International Business Unit - Medical Affairs - Neuroscience Therapeutic Area CRS OR CRP is to provide expert scientific support to all aspects of the international business in the Neuroscience therapeutic area, to ultimately enhance the customers' experience in interacting with the company. This includes international marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical/scientific 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 needed), and leading in international scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late phase and marketed compounds, but can also include early phase trials (for example, phase I and II trials). The CRS OR CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non clinical trial s
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