Senior Manager, Patient Programs
The Senior Manager of Patient Programs position is responsible for the following programs:
- Patient Support Programs (PSP)/ Patient Assistance Program (PAP) and Combination Patient Program (CPP).
- Named Patient Programs (NPP)
PSP, PAP and CPP are designed to support patients having a prescription of a Sanofi marketed product. These programs must be established in compliance with the highest ethical standards, national and international codes of practice applicable to the pharmaceutical industry, as well as all applicable international and local regulations and Sanofi global quality documents. The associate senior manager for patient programs provides expertise & medical oversight (governance) for these programs for all Sanofi Genzyme affiliates.
A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPP.
The PSP Medical Manager provides expertise & medical oversight of Patient Support Programs (PSP) and to a lesser extent of Patient Assistance Programs (PAP) within the Global Business Unit (GBU). The person will also be working closely with CSO and Program Management to monitor the status of each Named Patient Programs.
The position reports to the Head of Managed Access Programs (MAP) for Sanofi Genzyme and is a member of the MAP Leadership Team
- The PSP Medical Manager is expected to support rollout of the new PSP/PAP medical governance as well as to support the implementation of the new PSP/PAP tracking tool within the GBU.
- The PSP Medical Manager is the gate keeper for Medical processes around PSP and PAP and assists PSP Leads as well as local medical teams in navigating the medical processes (facilitator).
- The PSP Medical Manager is medical process owner for PSP within the GBU in case of audit or inspection. The PSP Medical Expert is the main CMO contact point.
- Classifying the various programs as PSP, PAP or CPP.
- Reviewing the concepts of the submitted programs
- Ensuring that the key principles are respected
- Patient programs must fulfill patient’s unmet needs in a given healthcare structure
- Patient programs must not be intended to drive prescriptions for Sanofi product or seek illegitimate sales advantage
- Patient programs must not be used to assess the efficacy and risk profile of a marketed Sanofi product
- Patient programs must neither replace nor change the Health Care Professional (HCP)’s role, decisions or prescriptions
- Patient must be informed and obtaining the patient’s informed consent is mandatory
- Health care professionals must not be compensated for proposing that their patients participate in a patient program
- Patient support programs must not include financial support to patients; this can be done only in PAP. Patient programs must be defined for a finite period and must not be open ended
- All patient programs must undergo an 18 month periodic review (renewal process) so as to ensure they always address the defined patient’s unmet medical needs
- Patient programs must comply with applicable laws, regulations and industry codes from the countries where they are conducted
- All patient programs related materials must be developed according to the standards defined and must be reviewed and approved in the appropriate current material management system and must be duly referenced (ID number).
- Acting as a resource available to the local teams.
- Reviewing all programs that have been initiated more than 18 months ago to ensure their relevance and that they still address unmet medical needs.
- In close collaboration with local PSP/PAP Leads, the Patient Programs Manager needs to check & make sure all programs within the GBU are tracked in the appropriate tool. This tracking includes the documentation of the complete medical review & approval process in case of initial request / design change / renewal as well as the monitoring of key selected items (product, country, number of patient enrolled, number of active patients, etc.).
- Ensuring that the programs are ready for audits and inspections and being the process owner in the event of audits and inspections.
- Minimum implication in PAP initial request / change of design / yearly renewal processes
- PSP Medical Expert will be part of the initial training, ie present/explain new Medical Governance to local PSP Leads & local medical teams within the GBU.
- Tracking tool: The PSP Medical Expert in the longer run needs to secure appropriate support to GBU (global & local) users including alerting ITS/CMO teams in case of inadequate support provided and helping find appropriate solutions.
For Named Patient Programs:
- Deciding with other stakeholders (medical, commercial, market access, alliance partners, etc.) the products and geographies of interest.
- Working closely with CSO and Program Management to monitor the status of each program
- Identify KPI’s and metrics
Qualifications & Requirements
- Required: Scientific or clinical degree in the life sciences. Preferred: Master Degree or Doctorate.
- 8+ years in the biopharmaceutical industry
- Clinical experience / Understanding of the medical environment.
- Ability to collaborate and build solid working relationships cross-functionally
- Patient programs experience, especially at the local level, would be considered as an asset
- Strong sense of ethics and business integrity.
- Excellent organization, planning and project management skills.
- Strong analytical and communication skills, both verbal and written
- Having worked at the country level is a plus
- Excellence in English language, verbally and written.
Reporting to: Head, Managed Access Programs, Sanofi Genzyme
Location: Cambridge, MA
Travel: Approximately 20 % travel required
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