Post-Trial Access (PTA) Coordinator
Sanofi
Chilly-Mazarin
il y a 5j

SUMMARY

Support the planning, decision-making, and implementation of Individual Post-trial Access to Investigational Product (IPTA2IP) and facilitate the continued provision of investigational products to eligible clinical trial participants who have derive clinical benefit during a clinical trial after trial completion in accordance with Sanofi’s Policy Position on Post-trial Access to Investigational Products.

JOB DESCRIPTION

The Post-Trial Access (PTA) Coordinator primary role is to work closely with and support the PTA Lead in coordinating all funded PTA requests and maintain the tracking of these requests through the review process and until the decision is communicated to the requesting physician.

The PTA coordinator responsibilities :

Request PTA Code

Organize PTA strategy meetings, kick off and oversight meetings with all stakeholders

Request PO Setup

Request set up in relevant tools Physician portal, PV Database)

Customize forms as needed

Assure relevant budget / timeline information is shared with appropriate internal stakeholders (eg, Clinical Trial Finance (CTF) and Operational Planning & Capacity Manager (OPCM))

Support the tracking of PTA budget and spend

Documentation Management, incl. vendor file transfer, review & reconciliation, and archiving & retention

Assure portal updates

Tracking launch / approval dates per product

Assure appropriate stakeholders (CSUs, Global / local medical etc.) are notified of PTA plans

Liaise with MAP coordinators

Compliance with applicable laws and regulations, as well as Sanofi policies, processes and procedures

The PTA coordinator’s main role is to support PTA requests however is also expected to serve as back-up to the MAP coordinators for Managed Access requests, which covers all locally defined pre-approval access mechanisms and programs such as :

Compassionate Use (CU) Cohort

Named Patient Requests

KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS

Knowledge and Skills :

  • Proficiency in MS office tools (Word, Excel, PowerPoint), O365 (including SharePoint and Teams) and Outlook are essential
  • Planning, organization and prioritizing, drive for results, respect of principles of confidentiality, flexibility, able to work both independently and effectively within a team, concern for quality, ability to be proactive
  • Experience working with contracts
  • Excellent communication skills (verbal and written)
  • Teamwork, sense of urgency, results oriented, commitment, proactivity, patient-centricity
  • Excellent customer service skills and a positive attitude are critical for engaging with internal and external partners
  • Required :

  • Bachelor’s degree in scientific / medical / finance or related fields
  • Desired / Preferred Skills & Qualifications :

  • Project Management experience
  • Ability to think strategically to foster ideas and act as a change agent, if needed
  • Previous experience with vendor and partnership management
  • Previous experience tracking and analyzing financial data
  • Ability to be self-sufficient with minimal supervision
  • 3+ years of experience in pharmaceutical industry administration setting is preferred
  • At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines.

    We believe in creating a diverse and inclusive workforce and workplace which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop.

    We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

    Sanofi Inc. and its 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.

    As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.

    All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

    Fully vaccinated, according to the CDC, an individual is considered to be fully vaccinated fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine.

    Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

    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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