Main Purpose of the Job:

Ensures that the local Medical Excellence & Operations activities and requirements are compliant with all applicable AbbVie processes and procedures, the Code of Business Conduct, ethics, regulatory requirements and the local laws.

This role should provide leadership, functional expertise and high-level project management to medical activities, that include evidence generation, planning processes, and management of Quality System documentation.

CORE JOB RESPONSABILITIES

• Participates and supports in medical operations responsibilities related to non-interventional studies, investigator-initiated-studies, collaborative research studies ensuring compliance with local laws, guidelines and AbbVie's internal requirements, interacts with Global, Area and local medical team regarding issues, timelines, resources and general activities.
• Builds up competence and support for medical affairs teams in strategic and innovative primary & secondary evidence generation (RWE) studies and projects (e.g. HTA).
• Ensures inspection and audit readiness.
• Supports implementation of Global Medical Excellence Programs locally: Tailors global programs to local needs, focusing on infield team excellence, and innovation.
• Supports creation and facilitates control of the Study Budgets for all evidence generation projects, liaising with financial department in PTP processes and oversighting correspondent invoicing. Manages local Vendor Services contracting related to evidence generation.
• Responsible for the maintenance of the local medical compliance with Quality System documentation applicable to Local Medical Affairs activities, such as procedures, working instructions, guidance or any other supporting documents owned by Affiliate Medical Department.