Evidence Generation and Medical Operation Specialist – Emirati National
Company Description
Abb Vie’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 Abb Vie, please visit us at Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.
Job Description DEPARTMENT FUNCTION AND OBJECTIVEThe 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 Abb Vie 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 Abb Vie.
- 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 Abb Vie guidelines and local regulations.
- 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…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).