Company Description
About AbbVie
AbbVie'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 Description
DEPARTMENT 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 FUNCTION
Lead 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 RESPONSIBILITIES
Study Execution Excellence
- Lead execution of all approved evidence-generation studies.
- Develop detailed implementation plans with clear timelines, milestones, budgets, and forecasts.
- Monitor study progress, risks, and mitigation actions throughout execution.
- Maintain study master files and ensure complete, compliant, and inspection-ready documentation.
- Support study-related audits and inspections as required.
CRO & Vendor Management
- Act as the primary contact for all CRO partners.
- Manage vendor selection and onboarding.
- Monitor vendor performance against defined KPIs.
- Conduct governance meetings with CROs.
- Review deliverables and quality outputs.
- Monitor contracts, purchase orders, and financial reconciliation.
Site & Investigator Management
- Coordinate investigator engagement activities.
- Support site identification and activation.
- Facilitate study start-up activities.
- Resolve operational study challenges.
- Coordinate study close-out processes.
Evidence Generation Portfolio Monitoring
- Track recruitment and overall study progress.
- Identify timeline or budget risks.
- Escalate critical issues to the Evidence Generation Lead and/or Medical Director.
- Provide monthly study-health updates.
Publication Lead Responsibilities
- Own affiliate publication planning.
- Lead publication strategy execution.
- Manage publication vendors and medical writers.
- Coordinate manuscript and abstract development and submission.
- Ensure publication compliance and required approvals.
- Secure required approvals for encore presentations of headquarters posters.
Scientific Communication
- Coordinate evidence dissemination activities across Medical, Market Access, and Commercial teams.
- Maintain publication trackers, budgets, and impact metrics, including usage across Medical, Commercial, and Market Access teams.
Qualifications
Education
- Bachelor's degree in Medicine, Pharmacy, Clinical Pharmacy, Life Sciences, Public Health, Healthcare Sciences, or a related healthcare discipline.
- Advanced degree (Master's) in Clinical Research, Epidemiology, Public Health, Health Economics, or a related field is a plus.
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
- Strong critical appraisal of scientific literature and ability to identify local evidence-generation opportunities.
Skills
- Strong project management and organizational skills.
- Ability to manage multiple stakeholders, studies, timelines, budgets, and vendors simultaneously.
- Strong analytical, communication, and problem-solving capabilities.
- Fluent in English and Arabic.
- Proficient in Microsoft Office applications and project/document tracking tools.
Additional Information
Interacts with, builds, and maintains professional and collaborative relationships with:
- Affiliate Medical Affairs leadership, Evidence Generation Lead, Medical Operations Specialist / Manager, Medical Managers/Advisors, Medical Science Liaisons, and Affiliate Safety personnel.
- Market Access, Commercial, Regulatory Affairs, Finance, Legal, Procurement, Compliance, and Clinical Operations colleagues, as applicable.
- Area, regional, and global Medical Affairs, Evidence Generation, HEOR, and publication stakeholders.
- Research investigators, study-site personnel, external experts, hospitals, healthcare providers, ethics committees, and local regulatory authorities.
- CROs, data-management providers, publication agencies, medical writers, and other third-party vendors.
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