DEPARTMENT FUNCTION AND OBJECTIVE

The local Medical Operations & Evidence Generation Team based in the Medical Department of the Gulf Levant Affiliate (Medical Director, Evidence Generation and Medical Operation Lead, Medical Operations & Evidence Generation Specialist) has the overall responsibility for the development and execution of the Affiliate Medical Operations & Evidence Generation strategic plans.

PRIMARY FUNCTION

• To provide set-up, coordination, and execution of centrally or locally sponsored, international, and local Non-Interventional Studies (NIS) as a member of the Medical Department of AbbVie in the Affiliate.
• Reporting to the Evidence Generation and Medical Operation Lead, this position represents the country/region expertise for post-marketing observational and other non-interventional studies. The position provides operational advice/guidance to the Affiliate Medical Affairs organization for multi-country or local projects.
• Work with the Medical Director to ensure that the Medical Department delivers value to the affiliate, patients, and the medical community through excellence in the planning and execution of medical projects and activities in preparation for launches (“Launch Readiness”), leadership of the Gap Assessment and medical anchors of the Brand Plans, in-field medical team effectiveness, evidence generation, medical education, and all medical initiatives. Ensure the quality of processes and compliance in the Medical Team through the development and control of procedures and documentation, conducting audits of service providers, conducting internal audits, in accordance with local regulations and global requirements of AbbVie.

MAJOR DUTIES AND RESPONSIBILITIES

Clinical Research and Evidence Generation

• To lead the development and execution of different types of evidence generation: non-interventional studies, Pharmacoeconomics studies, epidemiological studies, Real World Evidence in collaboration with internal stakeholders including but not limited to Medical and Market access.
• To ensure the development of the affiliate's evidence generation project plans.
• To manage the selection process of research sites and investigators, ensuring the engagement of investigators and institutions of high scientific relevance and in accordance with the corporate strategy.
• To support Medical Managers/Medical Director so that the evidence generation projects are aligned with the global and local strategies of the products and Therapeutic areas of interest, responding to scientific “gaps” validated with the “brands teams” of the affiliate.
• To ensure that all evidence generation procedures are in compliance with the regulations in force and SOPs in the area (local and global).
• To ensure budget planning and control of evidence generation projects, investigator-initiated studies as well as adequate payment from researchers, research sites and service providers.
• To support scientific partnerships with medical institutions and societies for scientific records, non-interventional studies, database analyses and other projects involving external collaboration.
• To ensure that “Evidence Generation” service providers are qualified, monitored/audited in accordance with AbbVie guidelines and local regulations.

Publications

• Serve as an Affiliate Publication Co-Lead.
• Ensure that the Affiliate’s Publication Plan is aligned with the Gap Assessment and Brand Plans.
• Support the development of scientific publications: results of local/regional studies, sub-analyses of global studies, pharmacoeconomic studies, database analysis, bibliographic reviews, and others. 
• To ensure that local scientific publications are developed in accordance with AbbVie's policies.
• To ensure that external authors have authorship criteria to manage so that activities related to publication are carried out in accordance with AbbVie's policies.

Medical Operations

• Support Evidence Generation and Medical Operation Lead in development and implementation Key Performance Metrics to measure the value and impact of Medical Affairs activities, ensure accurate and timely reporting to key business partners
• Support MO&EG Lead to plan and manage budget for the Medical Department
• To ensure the planning and maintenance of the Medical Team's quality process.
• To manage the development of strategies and planning for internal and external audits.
• To ensure the process of periodic development, control and updating of the Medical Team's organizational documents: organization charts, job descriptions, signature logs, CVs.
• To perform overall Risk Assessment of Medical related activities and advise Evidence Generation and Medical Operation Lead on specific actions that need to be in place and not limited to interactions of Medical In-Field Team with HCPs, Promotional and Non-Promotional materials, Fair Market Value Tiering, etc.
• Collaborate with cross-functional business leaders regarding HEOR processes, solutions, and initiatives to achieve shared business objectives. 

Others:

• Undergo and maintain training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to ICH GCP, AbbVie GPRD SOPs and IQS processes and procedures, local SOPs, applicable regulatory requirements, and study specific needs.
• Collect information from the market regarding market condition changes, registration regulations / guidelines, etc. changes and forward them to the direct supervisor regularly.
• Provide operational guidance where needed.
• Contribute to achieve satisfactory study audits.
• Ensure appropriate local SOP are in place to cover NIS conduct in the affiliate.