Head, xEVMPD and IDMP Strategy and Operations
Bridgewater, New Jersey, Cambridge, Massachusetts, Mississauga, Canada, Toronto, Canada, Laval, Canada
Head of xEVMPD & IDMP Strategy and Operations – Sanofi
Based from Reading UK or Bridgewater/Cambridge US, Quebec/Toronto CA, Dublin IE, Amsterdam NL
About the Opportunity:
This is a key role located within our Global Regulatory Operations (GRO) group under the Centralized Operations Team. You will lead the xEVMPD operations team and manage the end to end process that lead to xEVMPD submissions to the EMA. Have responsibility to monitor business process metrics and reporting, including leading/trailing indicators and overall adherence with EMA mandates. Be accountable for ensuring continuous improvement in partnership with the GRO Business Process & Operational Excellence team.
The Head of xEVMPD Strategy & Operations leads the xEVMPD support team and partners with business, Quality and other stakeholders within Sanofi and to ensure strong partnerships. This includes closely collaborating with Business Process and Operational Excellence team to direct changes to the XEVMPD process/system assuring alignment with compliance requirements and quality measures.
You will be the business process owner for IDMP submissions which is key to Sanofi’s successful implementation and compliance. As the Head, you will lead and work transversally across Sanofi ensuring the process, data and technology are in place to ensure compliance with this new agency requirements. To collaborate with BP&OE for the analysis related to the definition of processes and systems necessary for the strategy of the transition from XEVMPD to IDMP in compliance with EU requirements and timelines.
- Provide leadership and guidance on xEVMPD topics to manage internal and external changes to ensure Sanofi remains compliant for xEVMPD reporting.
- Lead the IDMP operational implementation within the Sanofi organization, ensure compliance to the EU requirements with regards to quality and timelines.
- Oversee requirement changes for IDMP, contribute and influence where needed to facilitate rapid implementation.
- Participate in internal and external working parties (with HAs, Industry, Vendors) to maintain compliance and ensure implemented systems and processes are evolving simultaneously with regulatory requirements.
- Represent Sanofi expertise during the xEVMPD/ IDMP audits and inspections.
- Deliver operational strategy and direction to the team.
- Analyze the operational activities of the team and define the corrective actions needed to ensure operational excellence (define processes, metrics, remediate technical gaps that currently exist).
- Collaborate with GRA Quality, Business Process and Operational Excellence and GRO Business Services to define Key Performance Indicators (KPI).
- Ensure adherence to KPIs and corresponding reporting and escalation, if KPIs are not met.
- Manage objective setting, assignment and performance appraisal for internal resources.
- Ensure team members are compliant with Training requirements.
- Partner with GRO Training and Development team to ensure that Users are made aware of changes to the system through communication and training.
- Maintain proficiency with xEVMPD/ IDMP related process and assure xEVMPD team does the same.
- Author and/or approve quality documents, namely SOPs and WINs, user guides, job aids, etc. and assume ownership as appropriate.
To excel in this role, you will need to have:
- This position requires a high degree of knowledge of Medicinal product information (structure of information on medicinal products and substances), Pharmacovigilance regulation (regulation 1235/2010 and related xEVMPD materials), Information standards to represent medicinal products and substances (Information Model), Knowledge of EU/EEA regulatory environment and related information systems (RIM).
- Regulatory domain knowledge, customer service with multiple interfaces with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, GPE, Industrial Affairs and Commercial.
- The position requires experience in managing complex issues in a global environment. Knowledge of additional functional areas (e.g. CMC, supply chain, clinical trials…) is a plus.
- Oversee quality control (QC) of Company xEVMPD records for submission to the European Medicines Agency (EMA) in line with requirements of Article 57(2).
- Experience in conducting, supporting and participating audits related to XEVMPD process.
- Strong verbal and written communication skills. Demonstrated ability to work in a global team environment, customer focused and action oriented.
- Experience in management of extended teams and stakeholders.
- Perform duties with integrity and trust; composure, and perspective.
- Strong interpersonal and collaboration skills.
- Bachelor's (University) degree in science, library or information management or equivalent experience. Minimum eight years’ experience in the pharmaceutical industry with a minimum of four years in regulatory affairs and three years in the Registration Data domain.
- Working knowledge of Article 57(2) requirements and EMA guidance documentation.
- Experience of using a xEVMPD submissions application.
- Strong knowledge of Regulatory Affairs/Operations domain, regulatory requirements and Regulatory Information (RIM) systems.
- Strong understanding of the different domains within Regulatory Affairs including Dossier Creation and Submission Management, Labelling, Document Management and reporting needs.
- Working knowledge of regulatory requirements in multiple jurisdictions.
- Ability to lead multi-disciplinary teams and interface with upper level management of support and client organizations.
- 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 very desirable.
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 fulfill 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.
At Sanofi diversity and inclusion is fundamental to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
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.
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