• 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.
• The 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 CRP serves as a scientific resource for study teams, departments, and others as needed.
• The CRP 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, SFDA, 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.
Main Accountability/responsibility
Business/ customer support (pre and post launch support):
• Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
• Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
• Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
• Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
• Support business-to-business and business-to-government activities as medical expert.
• Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
• Support training of sales representatives, and other medical representatives.
• Become familiar with market archetypes and potential influence on the medical interventions for the product.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert.
• Understand and apply knowledge of customer insights to all customer-related activities.
• Provide medical insight and training to patient support programs where applicable.
• Participate in local or national trade associations, as appropriate.
Scientific Data Dissemination/Exchange:
• Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
• Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
• Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
• Support medical information associates in preparation and review of medical letters and other medical information materials.
• Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.
• Prepare or review scientific information in response to customer questions or media requests.
• Provide follow-up to information requested by health care professionals as per global SOPs.
• Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Support the design of customer research as medical expert.
• Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).
• Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Clinical Planning:
• Communicate and collaborate with the Medical Director and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Medical Director and Business Unit Team Physician/Regional Medical Leader, as needed, global Medical Affairs and Development teams, Global Patient Outcomes/Real World Experience, PRA, Therapeutic Area Program Phase, and Early Phase /EPM /Translational Medicine teams.
• Communicate local/regional research needs and collaborate with other regions and the global Development and
• Medical Affairs teams, Global Patient Outcomes/Real World Experience, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
• Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
https://www.naukrigulf.com/physicia-jobs-in-riyadh-saudi-arabia-in-eli-lilly-and-company-1-to-5-years-n-cd-10003371-jid-160222501357
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