Title : Business Process & Operational Excellence Senior Process Analyst for Submission Management capability
Reports to : Business Process & Operational Excellence Lead for Submission Management capability
Group : Global Regulatory Operations
GRA is enabled by capabilities made up of a combination of process, data, and technology. The Submission Management capability includes Dossier Management, and Operational planning with 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 & Operational Excellence Process Analyst for Submissions Management capability is an analyst who can combine consulting, process excellence, 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 mainly GRO Submission Management, Information Technology Services (ITS) and other GRO departments as needed.
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 partners on standards and technology evolution.
This role will participate in the identification, delivery and evolution of projects linked to publishing activities within this Capability (e.
g publishing tools, validation and supporting tools, viewing tools, Submission gateways, eCTD 4.0 ). 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. The role reports to the Business Process & Operational Excellence Lead for Submissions Management.
Provide Level 3 process support for this capability
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 (for ex.
eCTD specifications and guidance updates)
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
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.
Strategic Projects / Initiatives for these capabilities
Identify and lead medium scale projects / initiatives (e.g : supervise data administration compliance for publishing purpose)
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.
User Project Lead (see Sanofi’s PUMA methodology)
Help defining user requirements, 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
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
Training & Change Management
Partner with the Regulatory Training and Development team to define the global training approach, materials, and delivery
Develop global cross functional stakeholder engagement strategies
Maintain User Access request set up
Participate to the End User system Training course content
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
Ability to work in an intercultural context
Strong organization and communication skills within a matrixed organization
Demonstrated ability to effectively influence leaders and team members.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.
All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status;
atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.