Title: Business Process & Innovation Senior Process Analyst for Registration Tracking, xEVMPD and IDMP capability
Reports to: Business Process & Innovation Lead for Registration Tracking, xEVMPD and IDMP Management capability
Group: Global Regulatory Operations
GRA is enabled by capabilities made up of a combination of process, data, and technology. Data is our future within Regulatory, and Registration Tracking is at the core of achieving it. This information is in demand to support product release, demand management, funding market opportunities, HA data driven environment (xEVMPD, IDMP, EU FMD, UDI, eCTD 4.0 and more) and sets the launching pad for data versus document driven world. This capability has a global footprint including eight (8) corporate sites plus the majority of affiliates. The Capability must be kept current, innovative and compliant with the constant changing Health Authority requirements to facilitate approvals of Sanofi products and their lifecycle management submissions. The capability enables the approval and compliance maintenance of Sanofi’s products in 163 countries requiring 50,000+ submissions per year.
The Business Process & Innovation Process Analyst for Registration Tracking, xEVMPD and IDMP Management capability is an analyst who can combine consulting, process excellence, change management, information modeling, modern Information Technology expertise with pharmaceutical and biotechnology regulatory knowledge to facilitate the ongoing transformation and continuous improvement for the capability.
This role is will work on the ongoing innovation of process, information and technology initiatives that maintain compliant operations as well as modernize workflow for the capability. This is done in partnership with GRA corporate plus affiliates, contributing functions (PV, Clinical, non-Clinical, etc.) and Information Technology Services (ITS). The role will work with these groups on future process, standards and technology evolutions. In addition to ensuring continuous improvement advances, the position will engage internal partners on standards and technology evolution.
This role will participate in the identification, delivery and evolution of projects within this Capability. The role will help ensure the maximum benefit is gained from the capability through a continuous improvement model. The role will be a change agent, byexecuting organizational change activities such as emails, meetings and key communications. The role reports to the Business Process & Operational Excellence Lead for Registration Tracking, xEVMPD and IDMP.
Strong direct input to capability strategy and roadmap aligned to the Sanofi business objectives, Health Authority requirements and with the ITS corporate strategy
Participates in the development and maintenance of end to end GRA process flows with an underlying information architecture
Keeps current on the marketplace evolution and potential application of information and technology, aligned to the overall GRA strategy
Supports compliance, audit readiness and operational stability
Facilitates process and information architecture, balancing the often competing needs of standardization and innovation
May be asked to provide input into decisions regarding resource alignment/dedication and prioritization (people resources, dollars/funding, project criticality) and communicates rationale
Applies compliance requirements within scope of responsibility, provides documentation as necessary, and participates in compliance activities as required
Supports and executes governance processes.
May be asked to mentor others inside and outside the organization order to help them deliver better business outcomes
Participate in the preparation of internal audits and external inspections for the capability
Analyst on mergers, acquisitions and divestitures to evaluate current state and create plan and target state for process, data and systems plus any transitional states.
Provide Level 3 process support for this capability
Strategic Projects/Initiatives for these capabilities
Identify and lead medium scale projects/initiatives
Manage from beginning to end medium scale projects, while setting and continually managing expectations with project sponsors, stakeholders and vendors.
Responsible for ensuring timelines and goals are accomplished per agreed charter and meet the required quality standards. Liaise with stakeholders on an ongoing basis and identify possible interactions with other projects / operations.
Support the development and management of system/business KPI for the Capability
User Project Lead (see Sanofi’s PUMA methodology)
Responsible for defining user requirements, organizing training, ensuring acceptance and deployment of the solution from a user perspective
May represent the System Owner during the project for minor systems
Participate in managing all user activities
Ensure the business process learns from the past, takes in industry trends, and maximizing technology to deliver an industry leading capability.
Participate in the facilitation and definition of User Process Monitoring for the capability including escalation and resolution paths in partnership with the Process Owners.
Participate in the facilitation and definition of Business Continuity plans in conjunction with the Business Process owner, ITS and other stakeholders
Participate in facilitation and provide input on the prioritize of requirements on what should be put into a future release based on highest business value
Develop and execute communications & updates related to change controls specific to the Capability
Facilitate business process/design changes across the organization for the Capability
Champion innovation and challenge ‘that is the way it has always been done’ approaches
Work with Business Process owner and other stakeholders in the design, authoring, maintenance of Quality Documents
Collaborate with super user community and/or business leads to define functional best practices
Serve as the Capability process SME for functional best practice & perform functional best practice reviews in accordance with the global process
Assess regression testing strategy impacts across capabilities and in accordance with user requirements
Review release notes and assess impact to business process & training based off of changes in functionality within the Capability
Training & Change Management
Partner with the Regulatory Training and Development team to define the global training approach, materials, and delivery
Represent input from User to system enhancement and feature request decisions for the Capability and Serve as a capability SME in collaboration with efforts to align cross capability process impacts due to external/internal system release schedules
Drive consensus on training material updates (e.g., CBTs, job aids) needed to ensure overall success of content of training within the capability
Develop global cross functional stakeholder engagement strategies
Develop, review and approve change strategy, approach, communication plan, and materials.
Support change engagement sessions (including leadership engagement sessions)
Review and approve at the project level communication/ engagement deliverables
Maintain User Access request process set up
Create End User system Training course content
Create, Validate Maintain the content for training material updates (e.g., CBTs, job aids, Demos) needed to ensure overall success of content of training
Support Super User Network and Functional Lead sessions and maintain Functional Lead/SuperUser Contact Details
Facilitate and drive defining the agenda, materials and follow-up actions for meetings with functional Leads, Super Users (1Q)
Lead defining the agenda, materials and follow-up actions for specific meetings with Functional Leads
Execute OCM Plan (emails, Meetings, communications) for the Capability
8+ experience, with experience in the pharmaceutical industry specifically enabling regulatory processes with data and technology.
Prior demonstrated experience leading process and technology projects in Regulatory.
Experience with Publishing global dossiers
Demonstrated ability to establish effective working relationships in different functions.
Strong organization and communication skills within a matrixed organization
Demonstrated ability to effectively influence leaders and team members.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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