Managed Access Program Specialist/spécialiste Du Programme D’accès Géré

Regina, SK, CA, Canada

Job Description

Length of contract: 1-year contract with possibility of extension.



Job Type


Full Time
English Version will follow



Apercu du poste:



Rejoignez notre equipe et contribuez a ameliorer l'acces des patients a des therapies qui changent la vie !



En tant que Specialiste du Programme d'Acces Gere (Managed Access Program Specialist), vous serez responsable de la gestion des demandes provenant des professionnels de sante, des etablissements de sante ou de Sante Canada pour acceder a un produit medicinal qui n'est pas approuve localement pour la mise sur le marche, qui n'est pas disponible commercialement, ou pour des demandes hors indication.Veuillez noter que ceci est un poste contractuel d'un an avec possibilite de renouvellement.



Responsabilites :


Agir en tant qu'expert(e) du Programme d'Acces Gere (MAP) au Canada, en fournissant des conseils et des formations aux equipes internes et aux parties prenantes externes. Servir de principal interlocuteur entre Sante Canada, les professionnels de sante, les etablissements et les equipes internes/globales impliquees dans la revision, l'approbation, la contractualisation, la liberation des medicaments, le suivi de la securite et le reporting. Superviser la gestion des stocks et des expeditions des produits MAP au Canada en collaboration avec la chaine d'approvisionnement et les fournisseurs externes. Etablir des contrats avec les demandeurs MAP conformement aux procedures operationnelles (SOP) et aux directives legales locales avant la liberation des produits. Gerer les bons de commande et suivre les depenses via les systemes tels que SAP et eShop, ainsi que realiser des activites de prevision et de rapprochement liees au programme. Traiter toutes les demandes MAP canadiennes conformement aux SOP locales/globales et aux reglementations de Sante Canada, en coordonnant les activites des parties prenantes. Assurer la saisie des donnees canadiennes dans les outils/systemes de suivi MAP locaux et globaux. Assurer un role oriente client en repondant rapidement aux appels et questions lies au MAP, en traitant les plaintes, en suivant les communications et en gerant l'archivage des documents. Representer l'organisation dans des forums de gouvernance mondiaux lies a la recherche, si necessaire. Effectuer toute autre tache requise.

Qualifications :


Diplome universitaire ou certificat d'etudes postsecondaires equivalent. Minimum 2 ans d'experience pertinente. Bilinguisme intermediaire (oral et ecrit) : anglais et francais. Comprehension des reglementations internationales et locales liees aux programmes d'acces special. Capacite a guider les clients dans des processus complexes et a interagir professionnellement avec les autorites sanitaires et les professionnels de sante. Aptitude a gerer un volume eleve de demandes simultanees avec precision. Engagement envers l'exactitude dans la documentation et la gestion des dossiers.

Exigences supplementaires :


Capacite a travailler dans un environnement de bureau standard et a utiliser l'equipement habituel, y compris un ordinateur (mouvements fins tels que la saisie et autres fonctions administratives). Endurance mentale pour maintenir l'attention aux details malgre les interruptions, et vision pour lire des documents imprimes et des ecrans. Flexibilite pour travailler des heures prolongees, y compris les soirees et les week-ends, afin de repondre aux besoins operationnels.

English Version


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Position Overview





Join our team and make a meaningful impact on patient access to life-changing therapies !



As a Managed Access Program Specialist, you will manage the process by which our client handles requests from Health Care Providers, Health Care Institutions or Health Canada for access to a medicinal product which is either not locally approved for market release, not commercially available, or for off-label requests.Please note that this is a 1-year contract with possibility of renewal.


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Responsibilities




Act as the Subject Matter Expert for the Managed Access Program (MAP) in Canada, providing guidance and training to internal teams and external stakeholders.

Serve as the primary liaison between Health Canada, Health Care Professionals, Institutions, and internal/global teams involved in review, approval, contracting, drug release, safety reporting, and tracking..

Oversee MAP product inventory and shipments in Canada in collaboration with Supply Chain and external vendors. Establish contracts with MAP requesters, per SOP and local legal guidance, prior to release of MAP products. Manage purchase orders and track expenses using applicable systems such SAP and eShop, and perform forecasting/reconciliation activities related to the Managed Access Program. Process all Canadian MAP requests, in accordance with applicable local/global SOPs and Health Canada regulations, by coordinating activities of involved associates. Manage Canadian data entry into applicable local and global MAP tracking tools/systems. Serve in customer-facing role, handling all MAP-related calls and questions from internal and external customers in a timely manner, addressing complaints, tracking communications and managing documentation archive. If required, act as local champion representing the organization at global research-related governance forums. Fulfill other duties as required.
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Qualifications




University degree or equivalent post-secondary education certificate 2 years of relevant experience Intermediate Bilingualism Oral and Written: English and French. Understanding of international and local regulations related to special access programs. Skilled in guiding customers through complex processes and interacting professionally with Health Authorities and Health Care Professionals. Ability to manage a high volume of concurrent requests with precision. Commitment to accuracy in documentation and case management.
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Additional Requirements




Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer (finite movements such as typing and other office functions). Requires mental stamina to maintain attention to detail despite interruptions, and vision to read printed materials and a computer screen. * Must be flexible to work extended hours, including weekends and evenings, to support operations requirements.

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Job Detail

  • Job Id
    JD3234262
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Regina, SK, CA, Canada
  • Education
    Not mentioned