RWE Studies Specialist
4 semanas atrás
Job Description
Important details (read before applying):
This is a temporary contract - with 1 year of initial duration with the extension to an additional year (2 years total).
We are looking for a professional preferably based in Brazil , however we are open to any other professionals within LATAM countries ;
If you are selected and you're not from Brazil, you will work from your current country.
Details:
The incumbent will join the Regional Outcomes research Latin America area. The person will have the primary responsibility for planning and managing outcomes research activities for our company products/ Oncology area on a Latin America basis and will report to the Oncology lead of the area. This includes all phases of outcomes research and real-world evidence needs including design and implementation of retrospective database studies, assessment of patient reported outcomes (PRO), epidemiological studies, and economic modeling.
The incumbent will work closely with local, regional, and global cross-functional teams, including leaders of regulatory affairs, scientific and medical affairs, public affairs, policy, market access, and other key areas to ensure outcome research programs are in line with marketing strategies in key countries.
The responsibilities include, but are not limited to:
General study management activities, including oversight of suppliers for value evidence activities;
Work with research laboratory colleagues, consultants, and suppliers to write, coordinate, and validate as required, study design, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications;
Work closely with the Latin American regional cross-functional team to develop outcomes research plans for our Company's in-line and new oncology molecules based on the regulatory, marketing and reimbursement/HTA/policy environment, including Latin America specific market needs;
Critically assess drivers and barriers to expand public and private market access in oncology and identify value evidence needs to demonstrate the value of our in line and developmental products/oncology;
Assist in the Implementation of programs to document disease burden and unmet need, PRO components, and health economic aspects of disease and the value of drug therapy as outlined in the outcomes research planning process/map and generates data to support pricing and reimbursement for countries in Latin America;
Develop value evidence deliverables (e.g., retrospective studies to generate country-specific data supporting patient access to company products/medicines;
Assist our Company's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossiers;
Present outcomes research data at international/national congresses and publish articles in scientific journals.
Mandatory minimum educational requirements:
Master´s degree or MBA from a school of medicine, public health, management, pharmacy, or economics;
Advanced proficiency in English;
Advanced proficiency in Spanish OR Portuguese.
Required Experience and Skills:
Demonstrated expertise in planning and managing real-world evidence activities, including design and implementation of clinical, epidemiological and cost studies;
Proven track record of success in planning and managing real-world evidence activities, including design and implementation of primary and secondary studies (database and chart-review), epidemiological studies, and cost studies;
Knowledge of principles of health economic modelling;
Experience in medical writing.
Preferred Experience and Skills:
International experience working in multiple countries in Latin America.
Solid experience working in the pharmaceutical industry, CROs, Consulting Firms and related.
Desired profile:
Proactive & ability to work in teams;
Excellent interpersonal, communication and strategic thinking skills.
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