Sanofi Job - 31002119 | CareerArc
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Company: Sanofi
Location: Cambridge, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

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.

There are instances where a patient has a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrollment into a clinical trial is not possible. In these cases, the treating physician can request an investigational / not authorized / not yet marketed Sanofi product prior to regulatory approval, provided it is allowed by the applicable local laws. Within Sanofi, we refer to such provision of products as “Managed Access.”

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)”
  • Others

The basic principles of Sanofi Managed Access are the following:

  • HCPs requesting access to drug must be unsolicited and the decision to proceed with the Managed Access Program must be substantiated by appropriate internal review and validation and must meet the following conditions:
    • Life threatening disease or condition for which there is no satisfactory alternative therapy
    • No possibility to participate in a clinical trial
    • Sanofi must be seeking regulatory approval for product (Compassionate)
    • Benefit/Risk profile defined and deemed sufficient to allow usage of Product

  • When the product is still under development (i.e. not registered anywhere - product or indication for medical condition, patient group, administration route and dose etc.)
    • Compassionate Use - Cohort (Group of patients as part of study)
    • Compassionate Use - Named Patient Program (Individual Request)
  • When the product is already registered or marketed in another country
    • Named Patient Program other type of Managed Access Program (Individual Request

      The Managed Access Program (MAP) Senior Coordinator primary role is to identify the 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. The position reports to the Head of Managed Access Programs (MAP) for Sanofi Genzyme and is a member of the MAP Leadership Team.

KEY RESPONSIBILITIES INCLUDE:

  • Primary point of contact for local medical teams globally for MAP questions, case submissions, process inquiries, etc.
  • 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
  • Responds to internal and external inquiries regarding Sanofi Genzyme's MAP;
  • 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 CMO Sharepoint site and ensure audit-ready environment
  • Identify best practices and operational efficiencies within SGZ MAP portfolio
  • Provide reporting and MAP program updates (as needed) to global medical teams
  • Participate in cross-functional Global MAP meetings to understand and anticipate pipeline products that would be eligible for MAP
  • 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
  • Assist medical teams to liaise with Global and/or MRP-TC secretary for all requests that require escalation
  • Assist France (ATU) and Canada (SPA)
  • 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
  • Maintain Global contacts lists for MAP communication
  • 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
  • Will be back-up to Humanitarian Programs Coordinator role

Requirements:

  • High School diploma, or higher, and 7+ years of experience; preferably in pharmaceutical or medical industry
  • 5+ years as an administrative assistant or coordinator in a professional office environment
  • 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

    Location:

    The person in this role must be located in Cambridge at 50 Binney Street.

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.

CORE COMPETENCIES:

  • Act for Change- embrace change and innovation to initiate new and improved ways of working. Essential sub-competencies for the roles include:
    • Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
    • Anticipates and attends to the human side of change, with speed, flexibility, innovation and forward thinking. Accelerates decision making by establishing clear accountabilities and simplified work processes.
    • Strong leadership presence w/ ability to present and interact with Sr Sanofi Management
  • Cooperate Transversally- collaborate effectively with peers, stakeholders and partners across the organization, within and across GBUs, to positively impact business results. Essential sub-competencies for the roles include:
    • Proven stakeholder management skills with senior/executive leaders, including comfort with ambiguity and a willingness to think independently.
    • Successfully integrates various and conflicting perspectives to achieve appropriate buy-in, bringing about the best outcome for the company as a whole.
    • Capability to operate and implement in a matrix organization, with and without direct supervisory control.
  • Strategic Thinking & Decision Making – ability to think and plan broadly and long-term to inspire excellence in execution and timely decision making based on information available. Essential sub-competencies for the roles include:
    • Ability to think strategically and communicate complex information in simple terms
    • Ability to propose creative solutions to operational/strategic issues, anticipating risks and propose mitigation plans
  • Commit to Customers- Understand, meet and excel internal and external customer expectations to create positive impact.

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.

#GD-GZ

#LI-GZ

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.


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