Clinical Science
hace 6 meses
395161BR
**Clinical Science & MIC Lead**:
Argentina
**About the role**
**Work Model**:Hybrid
**Locality**:Buenos Aires
**About the Role**:
Work with the Evidence Generation Lead to be a partner to the therapeutic areas (TA) in the development of relevant and impactful local scientific and medical evidence.
Enable the design and execution of scientifically rigorous, innovative RWE studies through the provision of methodological and analytical expertise and strategic input.
Ensure the research projects fulfil the scientific, methodological, and procedural concepts necessary to comply with Novartis standards for clinical studies, helping the medical team to achieve this requirement.
Focused on priority disease areas and gaps, this role is responsible for the development of an impactful and scientifically robust evidence strategy with emphasis on Secondary Use of Data (SUD) and innovative trial designs.
Manage processes for medical information services, aligning the needs of the CPO with Novartis requirements.
Promote the use of new digital technologies in the medical field to solve daily challenges.
Work together with the Business Excellence and Execution team for the implementation of management tools and visualization of KPIs.
Explore the opportunities and difficulties of implementing new technology in health care and navigate the healthcare barriers from stakeholders in analyzing gaps that can be closed with technology and data.
**Key responsibilities**:
Work with the Evidence Generation Lead with each TA Medical team to analyze local and global existing scientific and medical evidence, perform a strategic local gap analysis and generate their annual evidence generation plan accordingly.
Recommend data solutions to address evidence needs.
Help plan and review study concept sheets, protocols, and publications in order to drive the generation of quality local scientific evidence.
Help assess and select the appropriate study design according to main objective, timeline, budget, desired impact, final stakeholder, etc.
Ensure that the evidence is generated in the appropriate time according to the life of the product.
Help plan and implement local, regional, and global, pre-clinical and clinical, interventional and observational, phase IV and RWE studies, as well as pharmacoeconomic, population health and implementation research projects.
Help ensure the correct dissemination of the evidence to have a measurable impact on patients.
Constant cross-functional collaborative work with Medical, Access, HEOR, Finance, Legal, Data privacy, QA, Supply and Patient Safety colleagues.
Ensure that medical inquiries answered by the MI (Medical Information) department comply with data integrity requirements, alignment with regulatory processes and current product information, legal disclaimers, and other relevant considerations.
Ensure that the process of responding to medical inquiries is detailed in a local Standard Operating Procedure (SOP), aligned with the global SOP, and that this procedure is reviewed and approved by relevant functions such as Patient Safety (PS), Quality Assurance, Chief Medical Officer (CMO)/Medical Affairs Excellence (MAE) Head, or as defined, as applicable.
Ensure compliance with current procedures through continuous quality control of MIC (Medical Information Center) activities, by monitoring the involved areas.
Ensure latest methodologies and breakthrough technologies are implemented for Medical Affairs.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
**Essential Requirements**
Education : Degree in Heatlh Sciences.
Desired degree in relevant discipline including health economics, epidemiology, health services research, biostatistics, or public health
Languages: Advanced English
**Experience**:
Prior experience in scientific research or clinical research (phase III or IV studies).
Proven experience and knowledge of the scientific method, research project design, statistical analysis and scientific publication.
Preferably prior experience working in the Pharmaceutical Industry.
Digital saviness
**You’ll receive**:Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.
**Commitment to Diversity and Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
**Division**
International
**Business Unit**
LACan IMI
**Work Location**
Buenos Aires
**Company/Legal Entity**
Novartis Argentina S.A
**Functional Area**
Research & Development
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