Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.
At Alexion, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Associate Director, HEOR Real World Evidence Location: Barcelona
This is what you will do: The HEOR Real-World Evidence (RWE) Associate Director is part of the global HEOR team.
They will work with the RWE Centre of Excellence team, the International and Japan HEOR team, and the Medical Affairs RWE Champions in countries to support the development of the strategy, planning, and execution of Real-World Evidence (RWE), Real-World Data (RWD) projects and non-interventional studies (NIS) in countries and across the international region.
The HEOR RWE Excellence Associate Director will be responsible for providing support to RWE strategy development, planning, implementation, and execution of prospective and retrospective RWE studies including study deliverables, milestones, documentation, and communication.
They work closely with the cross-functional Medical Affairs team to follow and report Alexion-sponsored RWE study approval and progression regularly.
They will also work closely with and manage CROs in the setup, implementation, and follow-up of the progression of RWE studies, up to completion and deliverables of the report and publications, whenever required.
You will be responsible for: Development of RWE strategy, tactics & implementation plans of non-interventional studies and other RWD projects run in countries and across countries in the region. Work side-by-side with regions/countries to identify relevant evidence gaps, prioritize RWE needs, develop, and implement innovative solutions to close the gaps. Support the development of RWE strategies in the region across therapeutic areas, in collaboration with internal partners. Work closely with countries to facilitate the development of local RWE strategy, from study ideas to synopsis development in a timely manner, to produce meaningful and robust evidence to support product value demonstration aligned with local and regional needs (patient access, reimbursement, medical education, and patient advocacy). Develop strong internal and external partnerships to promote effective collaborations to generate high-quality RWE across multiple countries. Lead definition of standards and processes to manage quality, consistency, usability, security, and availability of RWE data. Define, monitor, and track RWE Study timelines and budgets with internal/external partners as well as Study Specific KPIs. Drive strategic planning and facilitate execution and close out of implementation of non-interventional studies (NIS) in close collaboration with the responsible CRO. Manage and oversee CRO to ensure the appropriate scope of work, oversight, and achievement of study milestones within agreed upon timelines and budget. Support the operational aspects of the work, such as ongoing study management, communication with CRO/centers including contracting activities to license and onboard database(s). Coordinate internal review of RWE Study proposals in alignment with study review committee. Ensure proper documentation/availability of RWE Study documentation in a Master file on the right ALXN repository either at local, regional, or global level, to ensure audit readiness. Prepare project plans, including governance processes and milestone tables for non-interventional RWE studies. Lead internal project management activities, development, oversight, and maintenance of study governance and review systems. Communication on RWE activities and studies in collaboration with the RWE country champions and Regional HEOR leads: Facilitate effective communication of research findings internally and externally through development of slide decks, intranet posts, meeting presentations, and other communication tools. Support the development of an efficient and targeted RWE publications plan in collaboration with scientific communications. Support the review process of RWE abstracts, posters, and manuscripts in collaboration with Scientific Communications. Ensure that the timelines of the publication's development are met. Team related RWE activities: Contribute to the development of department-level standards, tools, and templates and preparing 'best practices' and sharing in alignment with the Int'al & Japan RWE Lead & HEOR Lead. Contribute to the RWE Education program from ideation to elaboration and delivery of trainings to RWE Champions.
#J-18808-Ljbffr