Director, Pharmacoepidemiology
hace 5 días
Overview: Research Pharmacoepidemiologist Responsibilities:
RTI International is an independent nonprofit research institute dedicated to conducting innovative, multidisciplinary research that improves the human condition with a worldwide staff of nearly 6,000. Universities in North Carolina founded RTI in 1958 as the first scientific organization in—and centerpiece of—the Research Triangle Park, NC, USA. RTI Health Solutions (RTI-HS) is a business unit within RTI International focused on conducting research for pharmaceutical and medical technology companies. The Global Pharmacoepidemiology and Risk Management team within RTI-HS is based in the US (NC, MA) and Spain (Barcelona). RTI-HS is an active member of the International Society for Pharmacoepidemiology (ISPE) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Responsibilities will include:
- Leading strategic design, budget planning and writing proposals
- Designing studies, writing protocols and analysis plans
- Leading targeted or systematic literature reviews to support regulatory submissions
- Leading or contributing to feasibility assessments and landscape analyses
- Interpreting results, writing study reports and manuscripts
- Leading proposals, projects and strategic interactions with research partners, clients, internal contributors and management
Work will also include proposal and project planning and start-up activities, and other project management and research tasks in collaboration with the project manager.
Qualifications:
Qualifications:
- Doctoral degree in Epidemiology or related field of study and at least 8 years of pharmacoepidemiology experience, or equivalent combination of education and experience.
- Demonstrated experience in life sciences and pharmacoepidemiology
- Demonstrated understanding of good pharmacoepidemiology practice and regulations and international research networks in pharmacoepidemiology
- Ability to lead hybrid, multi-country teams and operate in a large matrix multidisciplinary and multisector environment across multiple locations and be flexible in taking on and performing assignments as necessary, including assisting other project teams, and to work to tight and sometimes challenging deadlines.
- Demonstrated effective communications (written, verbal and presentation skills) in a multinational and multidisciplinary collaborative environment.
- Ability to perform duties that require close attention to detail.
- Ability to establish and maintain effective working relationships with co-workers, supervisor, research partners and clients.
- Additional experience that is not required but highly valued includes:_
- Experience responding to requests from the European Medicines Agency (EMA), United States Food and Drug Administration (FDA), or other national regulatory agencies related to the pharmacoepidemiology field
- Prior experience working within a relevant research organization/institution including pharmaceutical industry and/or regulatory agencies, and participation at the International Society for Pharmacoepidemiology (ISPE) and/or European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- The working language is English. Additional language skills are a plus.
EEO & Pay Equity Statements:
As a global employer of choice, RTI is committed to equity, diversity, inclusion and belonging in the workplace and the communities and markets where we serve our mission. We value diversity of thought, culture, background and perspective and welcome applicants without regard to race, color, religion, sex, age, marital status, sexual orientation, gender identity, national origin, creed, citizenship status, disability, protected veteran status, or any other classification protected by applicable discrimination laws or RTI policy.
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.
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