Company DescriptionAbout AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionDEPARTMENT FUNCTION AND OBJECTIVE
The local Medical Affairs Evidence Generation function is responsible for translating approved evidence priorities into high-quality, compliant studies and scientific publications. The function delivers affiliate evidence plans through disciplined study execution, effective external-partner management, robust portfolio oversight, and timely dissemination of evidence across relevant internal and external scientific channels.
Primary FunctionLead end-to-end execution of approved evidence-generation studies and scientific publications through effective management of CROs, vendors, investigators, timelines, budgets, and scientific dissemination activities.
Reporting to the Evidence Generation Lead, the Evidence Generation Specialist / Advisor is responsible for operational delivery of the affiliate evidence-generation portfolio, including study planning and execution, site and investigator coordination, vendor governance, publication planning, documentation quality, inspection readiness, and performance reporting.
The role collaborates with Medical, Market Access, Commercial, Regulatory, Finance, Legal, Clinical Operations, and other relevant functions to support compliant and impactful generation and dissemination of scientific evidence.
Major Duties And ResponsibilitiesStudy Execution Excellence
CRO & Vendor Management
Site & Investigator Management
Evidence Generation Portfolio Monitoring
Publication Lead Responsibilities
Scientific Communication
QualificationsEducation
Experience* Minimum 3 years of relevant experience in Clinical Research Operations and/or Evidence Generation. * Demonstrated experience in study start-up, execution, monitoring, close-out, vendor management, investigator/site engagement, and budget tracking. * Experience in one or more of the following roles: + Clinical Research Coordinator (CRC) + Clinical Research Associate (CRA) + Clinical Project Lead (CPL) + Real-World Evidence (RWE) Lead + Clinical Operations, Study Management, or Research Management roles within pharmaceutical companies, CROs, hospitals, or research institutions.
Technical & Scientific Competencies* Good understanding of: + Clinical research methodologies and study management. + Real-World Evidence (RWE), observational studies, registries, and non-interventional research. + ICH-GCP principles, SFDA regulations, ethics committee requirements, and audit readiness. + Scientific publications, abstracts, posters, and manuscript development.
Preferred Additional Capabilities* Experience in research question ideation, evidence-gap identification, and development of evidence-generation strategies. * Experience in concept sheet development, protocol writing, protocol review, and study design. * Ability to translate scientific and clinical questions into executable research projects. * Experience in scientific and medical writing, including: + Study concepts and proposals + Protocols and synopses + Manuscripts, abstracts, and congress submissions + Clinical study reports and evidence dissemination materials
Skills
Additional Information
Interacts with, builds, and maintains professional and collaborative relationships with:
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
