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Lead, Governance and Systems, Managed Access Programs (MAP)

Cambridge, Massachusetts

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Job ID R2525323 Date posted 10/15/2019

Position Description

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 Market Authorization (MA) was withdrawn in 59 countries in 2012.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

Key Responsibilities

  • 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

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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