Lead, Governance and Systems, Managed Access Programs (MAP)
The Lead for Managed Access Programs Governance and Systems covers the following programs:
- Expanded access programs (also known as Compassionate Use Programs)
- Campath Program
Expanded Access (Compassionate Use) is defined as a sub category of Managed Access Programs, primarily covering Product in development not authorized yet. Patients with serious or life-threatening diseases or conditions may seek medical products that are not yet approved or available in their country.
Sanofi “Managed Access” addresses this need by making certain investigational or unapproved / not yet marketed treatments available to eligible patients.
Campath/MabCampath (alemtuzumab, 30mg/mL) was licensed in Europe as a treatment for Chronic Lymphocytic Leukemia (CLL) since 2001. Market Authorization (MA) was withdrawn in 59 countries in 2012. Campath is no longer commercially available in any country, except Japan. The MA was maintained in US, Australia, Canada and Japan to allow for global access plan. In Japan Campath is commercially available for CLL indication, but offered free of charge under Campath Access Program for other non-approved usages. To continue to provide drug to patients who may have a special need for Campath, Genzyme made the product available free of charge via the Campath Distribution Program, i.e., where acceptable alternative therapies may be lacking
The Lead for Managed Access Programs Governance and Systems is primarily responsible for the good conduct of our programs by establishing clear standard operating procedures and putting in place systems to consolidate ideally in a single location all key documents and data and that will facilitate the conduct of audits.
The position reports to the Head of Managed Access Programs (MAP) for Sanofi Genzyme and is a member of the MAP Leadership Team
- Creates standard operating procedures (SOPs) and update them on a regular basis
- Develop process flows and algorithms for the different programs
- Responsible to identify training needs, creation of materials and facilitation of training sessions; works closely with MAP Coordinator to ensure end-to-end training for local and regional medical teams
- Identifies and communicates MAP Best Practice strategies related to the conduct of our programs
- Identify risks and compliance gaps
- Performs and/or participates in periodic audit activities to ensure humanitarian program compliance; interfaces with markets and corporate audit teams as needed
- Identifies opportunities for continuous improvement to ensure efficiency and compliance
- Responsible, with the support of IT and vendors if needed, for creating a portal/Sharepoint site that will gather all key documents for the conduct of our business as well as for auditing purposes
Qualifications & Requirements
- Required: Scientific or clinical degree in the life sciences.
- Experience(s) in clinical research, medical operations, quality assurance or regulatory affairs is/are considered as asset (s)
- 8+ years in the biopharmaceutical industry
- Clinical experience / Understanding of the medical environment.
- Ability to collaborate and build solid working relationships cross-functionally
- Strong sense of ethics and business integrity.
- Excellent organization, planning and project management skills.
- Strong analytical and communication skills, both verbal and written
- Excellence in English language, verbally and written
- Proficiency in multiple languages is a plus
Reporting to: Head, Managed Access Programs, Sanofi Genzyme
Location: Cambridge, MA
Travel: Approximately 20 % travel required
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