FMD Operational Lead, xEVMPD and IDMP Support
Based Dublin - Ireland, Reading – UK,Chilly Mazarin and Marcy L'Etoile– France, Amsterdam – NL, Bridgewater or Cambridge - US
About the Opportunity
FMD (Falsified Medicines Directive), EU Directive 2011/62/EU, are a set of measures aimed at ensuring falsified medicines are not entering the legal supply chain and reaching patients. Sanofi have an opportunity available for you to join our Global Regulatory Operations group under the Centralized Operations team where you will be overseeing the successful master data gathering and mapping of Finish Goods (FG) and Packaged Medicinal Product (PMP) information for Industrial Affairs.
Overseeing a team, will ensure timely action of master data mapping and stakeholder communications. Monitor KPI and metric generation/distribution to key stakeholders. Product master data collection required to support the FMD implementation and work with Strategic FMD Leader, as needed, to review and improve the process and associated training materials.
For xEVMPD, you will provide responses to inquiries from health authorities and collaborates with the xEVMPD Operations team to provide ad-hoc support. For IDMP, this includes supporting the implementation of transition from xEVMPD to IDMP in compliance with EU requirements and timelines.
Lead a team of FMD operational coordinators to ensure Sanofi remains compliant with the EU Directive 2011/62/EU
Execute operational strategy and direction to the team
Collaborate with the Strategic FMD Leader and Operational Excellence team to implement continual improvement strategies for the master data mapping process
Ensure data quality and compliance monitoring of the master data mapping activity
Liaise with Strategic FMD Leader escalating master data mapping critical issues for remediation with stakeholders
Monitor metric dashboard generation and communication for Key Performance Indicators (KPI)
Manage the Business Support staff to ensure productivity and efficient use of resources
Identify potential issues and project conflicts. Drive to identify and resolve issues to ensure timely and accurate resolution of problem tickets. Alert management as needed
Maintain continual awareness of system operation, configurations and business requirements
Maintain reference material for operational and audit/inspection purposes
Provide input to the creation of quality documents, namely SOPs and WINs, user guides, job aids, etc.
Collaborate with FMD Operation Coordinators and appropriate stakeholders to identify and resolve issues related to the master data mapping process
Support the xEVMPD operational resource team to ensure Sanofi remains compliant for xEVMPD reporting
Author responses to xEVMPD inquiries from health authorities and collaborate with internal stakeholders prior to submission of these responses
Support the IDMP operational implementation within the Sanofi organization, ensure compliance to the EU requirements with regards to quality and timelines
To excel in this role, you will need to have:
Bachelor’s (University) degree in Science, Library or Information Management or equivalent experience
Pharmaceutical industry experience supporting Regulatory Affairs and Registration Data domain
Knowledge of Regulatory Affairs/Operations domain, regulatory requirements and Regulatory Information (RIM) systems
Experience of accessing and retrieving documentation from electronic document management systems
Experience of using an xEVMPD submissions application is desirable
Working knowledge of regulatory requirements in multiple jurisdictions
Working knowledge of Article 57(2) requirements and EMA guidance documentation is desirable
Strong interpersonal skills to be effective in the leadership of global teams
English is required at a fluent level
Knowledge of other EU languages is desirable
What Sanofi can offer you:
A role where you are instrumental to creating best practice and as the organisation grows, you can too
We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfil your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
Thank you for your interest in Sanofi and we look forward to hearing from you!
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.