Job Description

Johnson & Johnson, through its operating companies, is the world\'s most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high-quality products and services to help heal, cure disease and improve the quality of life.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Inc. is part of the Janssen Pharmaceutical Companies.

Role Summary:

The Manager Patient Assistance and Special Access Programs is responsible to manage the end-to-end processes of the medical review and provision of drugs through Special Access Programs and through Programs mechanized by Medical Sciences (Patient Assistance Programs) and through programs mechanized by other established Patient Support Programs. The Manager Patient Assistance and Special Access Programs is the assigned designated authority, responsible for the document management coordination, and document retention related to unsolicited requests for access to drugs and ensures that medication release, refill and delivery is coordinated in accordance with the medical review completed by Medical Director/Trained Designee. The key accountabilities for the Manager Patient Assistance and Special Access Programs include medical review and assessment, medical review compliance monitoring, development of relevant metrics and generation of reports for review by senior leadership and cross-functional partners, creation, and revision of related procedural controlled documents, streamlining and automation of the related processes.

Major Responsibilities:

\xc2\xb7 Oversees, supports, and acts as first line response and managing activities responsible for Special Access Programs (SAPs), including communication with Health Canada and all other external/internal business partners.

\xc2\xb7 Manages the provision of drugs through Patient Assistance Program mechanized by Medical Sciences.

\xc2\xb7 Completes documented and criteria based justified medical review assessment in response to requests from HCPs.

\xc2\xb7 Manages compliance monitoring conduct for medical review assessment and the related records management and dashboards.

\xc2\xb7 Supports the development and execution of patient request adjudication criteria in collaboration with the functional area Director and Scientific Advisor and TA Medical Directors.

\xc2\xb7 Manages the procedural documents (i.e., SOPs/Work Instructions) for Patient Assistance for Access to Drugs, including accountability for medical science processes and operational execution, as well as leading the continual review and necessary updating of the processes and procedural documents. Continues to assess, develop, and expand access processes to ensure improvement/optimal use and continued compliance with Janssen guidance documents.

\xc2\xb7 Manages ongoing medical communication with HCPs, including documented medical review response and medical justification as applicable.

\xc2\xb7 Tracks and trends the access to drugs requests and prepares dashboard metrics for communication to senior leadership and cross-functional business partners.

\xc2\xb7 Streamlines and automates the provision of drugs processes in collaboration with MA Systems group and local IT cross-functional business partners (MA Systems, IT, Supply Chain, Customer Logistics) to create efficiencies and minimize duplicate entry of information.

\xc2\xb7 Ensures development of automated reports for provision to senior leadership as requested.

\xc2\xb7 Communicates project status updates, medical review, and provision of drugs status of Patient Assistance and Special Access Programs to all stakeholders, including senior leadership, as needed.

Johnson & Johnson