Description

About the Hiring GroupRTI Health Solutions (RTI-HS), a wholly owned subsidiary of RTI International, is an independent and internationally recognized research organization. With offices in the US, UK, Spain, France, and Sweden, we provide healthcare consulting and research expertise to optimize decision making for pharmaceutical, biotechnology, and medical device products across the development, regulatory review and post-approval lifecycle. Clients rely on our expertise, quality standards, and integrity to guide their product development and regulatory and market access strategies. Our various practice areas include Epidemiology and Biostatistics; Value, Access, and HEOR; Patient-Centered and Outcomes Research; Medical Communications; Global Business Operations; and Strategic Consulting and Growth.The Epidemiology / Regulatory Real-World Evidence (RWE) team, within RTI-HS is currently based in the US (NC, MA, other), and Spain (Barcelona). We are active members of the International Society for Pharmacoepidemiology (ISPE), the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), the Vaccine Collaboration for Europe and charter members of the RWE research hub SIGMA Consortium. Information about our studies can be found in RTI-HS | HMA-EMA RWD Catalogues. The office in Barcelona hosts 25 epidemiologists and biostatisticians. At RTI-HS, you will be provided with the opportunity to conduct meaningful work in a collaborative, cross-functional environment, and flexible work schedule.This role is based in the Barcelona, Spain office, with a minimum in office requirement of two days per week. What You'll DoWe are looking for someone with a strong combination of skills and experience in pharmacoepidemiology, risk management, and other regulatory-grade real-world evidence (RWE) research, along with the ability to work effectively in a collaborative, multidisciplinary research environment. In this role, you will contribute to, or co-lead, in collaboration with a Senior Epidemiologist, field and database regulatory-grade studies on the use, safety, and effectiveness of treatments and prevention across a range of therapeutic areas. This includes supporting pre- and post-approval regulatory applications of RWE, such as external control arms and label extensions.To be successful in this role, you will possess:Demonstrated effective communication skills (written, verbal, presentation) in a cross-functional, collaborative environment.Ability to establish and maintain effective working relationships with research and operations staff, research partners, and clients.Ability to work effectively within large, matrixed, multidisciplinary, multisector teams across multiple locations and under tight timelines.Ability to contribute to or co-lead study design, protocol, reports, and manuscripts, including document writing, and project communications, budget planning and proposal and to assist other project leaders in these activities when needed. What You'll NeedLife sciences background with master's degree in Epidemiology or equivalent and 6 years of pharmacoepidemiology experience, PhD in Epidemiology and 1 year of pharmacoepidemiology experience, or equivalent combination of education and experience. Experience in causal inference target trial emulation framework, computational/AI epidemiology, responses to EMA, FDA, or other regulatory agencies regulatory requests relating to risk management planning, and/or design/implementation and reporting of post-marketing safety studies is highly valued. Prior experience working within a relevant research organization/institution including pharmaceutical industry and/or regulatory agencies is highly valued.The working language is English; additional languages will be highly valued

Responsibilities

We are looking for someone with a strong combination of skills and experience in pharmacoepidemiology, risk management, and other regulatory-grade real-world evidence (RWE) research, along with the ability to work effectively in a collaborative, multidisciplinary research environment. In this role, you will contribute to, or co-lead, in collaboration with a Senior Epidemiologist, field and database regulatory-grade studies on the use, safety, and effectiveness of treatments and prevention across a range of therapeutic areas. This includes supporting pre- and post-approval regulatory applications of RWE, such as external control arms and label extensions.To be successful in this role, you will possess:Demonstrated effective communication skills (written, verbal, presentation) in a cross-functional, collaborative environment.Ability to establish and maintain effective working relationships with research and operations staff, research partners, and clients.Ability to work effectively within large, matrixed, multidisciplinary, multisector teams across multiple locations and under tight timelines.Ability to contribute to or co-lead study design, protocol, reports, and manuscripts, including document writing, and project communications, budget planning and proposal and to assist other project leaders in these activities when needed

Qualification

Life sciences background with master's degree in Epidemiology or equivalent and 6 years of pharmacoepidemiology experience, PhD in Epidemiology and 1 year of pharmacoepidemiology experience, or equivalent combination of education and experience. Experience in causal inference target trial emulation framework, computational/AI epidemiology, responses to EMA, FDA, or other regulatory agencies regulatory requests relating to risk management planning, and/or design/implementation and reporting of post-marketing safety studies is highly valued. Prior experience working within a relevant research organization/institution including pharmaceutical industry and/or regulatory agencies is highly valued.The working language is English; additional languages will be highly valued