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Excelya

Ile-de-France, France 27/08/2022
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Healthcare Business analyst




Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.


We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.


For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.


To learn more about us, visit www.excelya.com




The heathcare business analyst is responsible to manage and coordinate the Medical Affairs training with respect of the regulatory guidelines standards and to ensure the delivery of the training to Global and Local Medical Affairs community. his/her’s responsibility covers all Medical Affairs processes.




Experience:


· At least 3 years in international pharmaceutical similar function or with good knowledge in QA compliance documentation, including experience with support and maintenance




Special skills:


· Excellent written and oral communication skills, ability to deliver concise messages


· Ability to work through difficult issues, assimilate and analyze information efficiently


· Tools/Systems ability




Languages:


English fluent mandatory



Training Curriculum



Define and maintain up to date in collaboration with QA representatives, Quality Management System (QMS) and Medical Affairs leadership team the appropriate training curriculum for all third parties that are involved in Medical Affairs activities.
Implement the appropriate process to maintain the different curriculum training on an ongoing basis
Liaise with process owners and trainers to ensure appropriate training material is generated and made available
Work with the Global Quality Document controller to agree effective dates for QMS documentation and ensure training is in place and training curricula updated prior to ‘go-live’
Contribute to the R&D / CMO functions _Training Plan (annual training plan)



Training Content & Delivery



Coordinate with process owners the preparation of the training content and delivery
Ensure that all training content are maintained up to date specially to Medical Affairs newcomers



Training Compliance



Set up relevant quality documentation (Policy and SOP) to support the entire Medical Affairs activities
Implement and maintain the relevant training trackers to capture training effectiveness & compliance
Identify and monitor relevant key performance indicators (KPIs) that measure the level of performance and compliance of Medical affairs processes



Audits and Inspections, including inspection readiness:



Support the audit activities from the conduct to closure by providing requested information in due time until follow-up of CAPAs implementation and ensure timely completeness
Drive the preparation and follow-up of any regulatory inspection in conjunction with QA



Quality reporting:



Participate in the Quality Governance Committee
Request Status /tracker from QMS (monthly)
Coordinate reminders received with owners and follow with QA rep (for evidence…)
Creation of Distribution list and Review of distribution list
Respond to impact analysis outputs where applicable











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