Manager of xEVMPD & IDMP Operations
Bridgewater, New Jersey, Cambridge, Massachusetts, Mississauga, Canada, Toronto, Canada, Laval, Canada
Manager of xEVMPD & IDMP 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 Central Operations Team. You will lead xEVMPD operations, submissions, acknowledgements and responses to all inquiries. Implement the end to end process from business operations perspective. Identify opportunities/trends/risks that correlate to late submissions, creating and executing action plans and escalating to management for timely action when necessary.
As the manager you will collaborate with the extended xEVMPD support team, business, quality and other stakeholders within Sanofi. For xEVMPD, this includes closely collaborating with Business Process and Operational Excellence team to direct changes to the XEVMPD process/system in line with compliance and quality. For IDMP, this includes contributing to the analysis related to the definition of processes and systems necessary to develop the strategy for the transition from XEVMPD to IDMP in compliance with EU requirements and timelines.
- Lead a team of xEVMPD operational resources to ensure Sanofi remains compliant for xEVMPD reporting.
- Support the IDMP operational implementation within the Sanofi organization, ensure compliance to the EU requirements with regards to quality and timelines.
- Provide expertise during the xEVMPD/ IDMP audits and support the audit and inspection process with responses and reports as requested.
- Monitor with GRA Quality, Business Process and Operational Excellence and GRO Business Services Key Performance Indicators (KPI).
- Ensure adherence to KPIs and corresponding reporting and escalation.
- 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 proficiency with xEVMPD/ IDMP related process and tools and assure xEVMPD team does the same.
- Support the implementation of changes to existing tools and system implementation projects.
- Provide input to the creation of 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:
- 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.
- Experience in managing complex issues in a global environment. Knowledge of additional functional areas (e.g. CMC, supply chain, clinical trials…) is a plus.
- Create, Review, and carry out quality control (QC) checking of Company xEVMPD records for submission to the European Medicines Agency (EMA) in line with requirements of Article 57(2).
- Collaborate with Company RA personnel to acquire missing xEVMPD submissions data or to obtain clarifications required to complete xEVMPD record submissions.
- Experience in conducting, supporting and participating audits related to XEVMPD process.
- Experience with drafting and submitting responses to heath authorities.
- Solid expertise and effective use of data analysis tools and collect, summaries and present information.
- Strong verbal and written communication skills. Demonstrated ability to multi-task and to work in a global team environment, customer focused and action oriented.
- Experience in management of extended teams and stakeholders.
- Ability to effectively lead and/or participate on teams.
- Perform duties with integrity and trust; composure, and perspective.
- Strong organizational and communication skills.
- Problem-solving skills and the ability to construct investigations to collect data aimed to support a pre-determined hypothesis.
- Bachelor's (University) degree in science, library or information management or equivalent experience. Minimum six 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.
- Experience of accessing and retrieving documentation from electronic document management systems.
- Strong knowledge of Regulatory Affairs/Operations domain, regulatory requirements and Regulatory Information (RIM) systems.
- Strong VAULT RIM and Business Objects Universe design, creation, testing and technical skills are desired.
- 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.
- 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 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.
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