Sanofi
About the job
Our Team:
Patient programs (PP) are designed to enhance disease management after patients are prescribed Sanofi’s product. The initiative focuses on providing patient education, financial assistance and defined patient support. The Patient Solution Manager will take on the Patient Program Lead (PPL) role overseeing the patient program in alignment organizational structure.
Main mission
The Patient Program Leader (PPL) is responsible and accountable for building and conducting the Patient Programs (PP). This includes but is not limited to the following:
- Set up and lead the cross functional team
- Monitor program performance with key local and global performance metrics
- Ensure PP is captured in the Global Tracking Tool (Patient Program Tracker – PPT), updated according PP evolution, and kept up to date as per effective.
- Manage Services Providers
- Identify and manage deviations and risks associated with management of PPs
Interactions:
The PPL interacts with the cross-functional team assigned to the PP:
- Country Medical
- Country Marketing
- Country Safey Head/Lead
- Country Regulatory Manager or delegate
- Local Privacy Officer
- Local Procurement
- Global PP Medical Expert
Ad-hoc representatives from other functions as per PP needs
JOB DUTIES AND RESPONSIBILITIES:
1. PP design definition and PP set-up
PPL is responsible for leading a cross functional team to define, set-up and monitor a Patient Program in accordance the GOP and local laws and regulations in effect. This includes but is not limited to:
- Development of documentation to describe PP design and objectives in alignment with patient needs and brand strategy
- Ensure adequate materials are developed for the purpose of the program, reviewed, and approved. Ensure Website or Apps are developed, as per PP design, with the support of appropriate functions
- Ensure Informed Consent(s) (IC) for patients and HCPs when applicable is developed and approved with the support of appropriate functions
- Identify opportunities to evolve further program and vendor performance excellence through governance, communications, performance measurement and management
2. Global System Tracking and Monitoring
Responsible to ensure:
PP is tracked in the Global Tracking Tool, as per process requirements defined in the GOP, ensuring reviewer comments are addressed, as needed, and resubmit for review and approval
All pertinent information and documentation are up to date.
On a monthly basis, update patient enrollment information and PV requirements
3. Services Providers and Program Performance Management
PPL is responsible for:
- Selection of Services Provider (SP) and partner with procurement to lead the RFP process
- Qualification of Services Provider with the support of appropriate functions
- Ensure PP requirements are described in the contract agreement with the Services Provider
- Ensure the SP staff are appropriately trained
- Define reporting needs for each PP and ensure the Services Provider delivers all appropriate reporting
- Oversee activities managed by the SP – ensure the PP is conducted by the SP as per contract (e.g. collection of IC, use of validated script, compliance with data privacy laws, etc.)
- In collaboration with Procurement and other cross-functional stakeholders, create and manage PSS vendor partnership governance, communications and performance assessment
4. Pharmacovigilance & PTC Reporting:
Monitor and enforce adherence to Pharmacovigilance (PV) and Product Technical Complaint (PTC) reporting protocols.
Ensure that all adverse events and quality concerns are reported promptly and managed in compliance with Sanofi's regulatory and safety guidelines.
Work closely with PP service provider to uphold quality standards and maintain program integrity.
Ensure all Adverse Events (AEs) are reported to the Sanofi Pharmacovigilance Team within 1 working day.
Ensure PTC reports are submitted to the Country Quality Team within 1 working day.
Work with third-party providers to maintain data accuracy and compliance with SOPs.
5. Compliance:
Ensure strict adherence to compliance standards governing PP activities under the guidance of patient solutions Lead and PPL Manager. Enforce patient engagement protocols that align with SOPs, data privacy guidelines, and regulatory requirements.
· Data Privacy Compliance: Patient Program lead must not handle patient data, per the SOP for Data Privacy Compliance.
Patient data must be managed by third-party providers, ensuring compliance with relevant privacy policies.
No unauthorized data access or sharing by Sanofi employees, maintaining strict compliance with regulatory requirements.
Required educational background and job-related experience:
Education
Graduate in Science, Pharmacy, Social Work, PharmD, PhD and other Scientific profiles.
Professional expertise and experience
- 5+ years’ experience as project leader or oversight experience - in matrix organization.
- Patient Program (PP) experience preferred.
- Affiliate/operational experience is a plus.
- Demonstrated experience developing and delivering patient-centric solutions that improved access to therapy; experience piloting new PSS digital capabilities is an asset
- Experience managing programs across various stages of the product lifecycle (e.g. new product launches, new public and private reimbursement coverage, and loss of exclusivity)
- Demonstrated experience leading operational efficiency and effectiveness initiatives that improved patient access to therapy
- Strong leadership/management and analytical skills, ability to delivery on project objectives in a timely manner required
- Proven ability to lead and influence teams without direct authority
- Proven ability to communicate and present effectively to senior leaders, cross-functional and cross-organizational teams in a matrix environment
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!