Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Primary Job Function
The role ensures compliance with Cluster North laws and AbbVie's guidelines in executing Multi Country Observational Studies (MCOS) and oversees their conduction, tracking, remuneration, and database management. It leads the development of evidence generation projects, supports medical affairs teams, manages audits, and participates in gap assessment processes. The role aligns projects with global and local product strategies, leads regulatory processes and scientific partnerships, and supports the Medical Director in budget planning.
Core Job Responsibilities
- Ensure MCOS compliance with Cluster North laws and AbbVie's SOPs/guidelines.
- Oversee MCOS conduction, tracking, remuneration, and database reporting.
- Lead diverse evidence generation projects and support medical affairs in Real World Evidence (RWE).
- Manage strategies and planning for audits and ensure service provider qualifications.
- Participate in the "Gap Assessment" process and manage the selection of investigation centers and investigators.
- Align evidence generation with product strategies and lead regulatory and scientific collaboration efforts.
- Manage metrics and KPIs and support budget planning for Medical Direction.
- Ensure that brand teams are informed about evidence generation and publications.
- Publications
- Lead and manage scientific publications, including planning and budget tracking.
- Ensure compliance with AbbVie policies in publication activities.
- Support internal and external processes for publication execution.
- Address publication project issues, minimize deviations, and train staff.
- Ensure the dissemination of locally generated evidence.
Qualifications
- Complete higher education in the health area or an equivalent combination of education, training, and experience. Postgraduate studies in clinical areas, Pharmacology, Epidemiology, or business are preferred.
- 3+ years in the pharmaceutical industry and 1+ years in medical matters.
- Familiarity with GCP, pharma SOPs, MS Office.
- Advanced knowledge of Clinical Study Management and Scientific Publishing.
- Desirable knowledge in Clinical Research, Pharmacoeconomics, Pharmacovigilance, Quality, Financial Management.
- Fluency in English is highly desirable.
- Understanding of medical and business planning processes.
- Experience in stakeholder relationship development.
- Good knowledge of ICH-GCP guidelines and local regulations.
- Multifunctional teamwork approach, project management skills, and adaptability to computer systems.
Desirable
- Doctorate in a scientific discipline (M.D., Ph.D., Pharm.D.).
- SCRUM Master certification.
- Experience in therapeutics, medical marketing, and training.
- Understanding of drug discovery, development, and HCP interactions.
- Knowledge of Abbvie therapeutic areas and advanced clinical study processes.
- Experience with medical strategy technologies.
Additional Information
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