The Managed Access Program (MAP) Project Manager’s primary role is to identify the Managed Access requests belonging to Sanofi Genzyme from the Sanofi Portal and to maintain the tracking of these requests through the review process and until the decision is communicated to the requesting physician.
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.
The Sanofi Managed Access terminology covers all locally defined pre-approval access mechanisms and programs such as : Compassionate Use , Expanded Access , Named Patient Supply , Special Access Schemes / Programs , Autorisations temporaires d’utilisation (ATU) and others
Project manager is the Owner of case submission process including verifying completeness of documentation, communication with Global Medical, recording decisions and country follow-up while ensuring compliance to MAP SOP
Local Medical teams
Global Medical teams
MAP GBU Coordinators
Duties & Responsibilities
Primary point of contact for local medical teams globally for MAP questions, case submissions, process inquiries, etc.
Responds to internal and external inquiries regarding Sanofi Genzyme’s MAP;
Provide reporting and MAP program updates (as needed) to global medical teams
Maintain Global contacts lists for MAP communication
Receive and track all MAP requests within SGZ portfolio ensuring evaluation and response to requesting physician are completed in a timely fashion
Upload and organize all relevant documentation within SharePoint site and ensure audit-ready environment
Identify best practices and operational efficiencies within SGZ MAP portfolio
Participate in cross-functional Global MAP meetings to understand and anticipate pipeline products that would be eligible for MAP
Assist medical teams to liaise with Global and / or MRP-TC secretary for all requests that require escalation
Owner of MAP documentation including criteria, application forms, decision letters and training manuals; Partnering with Medical, Legal and Compliance teams to ensure documentation meets patient privacy requirements and disease specific guidelines
Prepare and provide documentation to support audit-related activities to ensure compliance with Sanofi policies & procedures at the local, regional and global level
Manage temporary help as needed (interns, contractors, etc.)
Participates in department projects as needed
Liaise with medical teams to collect feedback on MAP process, identify pain points, and modify governance process / documentation as needed to comply with local regulations
Work with all MAP GBU coordinators and CMO office to evaluate MAP scope and program needs
Knowledge, Skills & Competencies / Language
Strategic thinking and decision making
Commit to Customers
Ability to work independently and within a team environment
Excellent English language knowledge written and spoken
Bachelor / Master with 10+ years of experience in Pharmaceutical or medical industry (preferably with managed access programs)
5+ years of relevant experience in Project Management
Requirements of the job
Patient-focused; demonstrates good common sense and compassion
Strong administrative and organizational skills
Ability to take initiative, work well under pressure and work with people from different functions
Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint).
Excellent written and verbal communications skills with demonstrated ability to convey critical and sensitive information in a highly professional manner
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.