Manager Patient Assistance And Special Access Programs

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

• Ensures development of automated reports for provision to senior leadership as requested.
• 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.
• Manages compliance monitoring conduct for medical review assessment and the related records management and dashboards.
• Completes documented and criteria based justified medical review assessment in response to requests from HCPs.
• Tracks and trends the access to drugs requests and prepares dashboard metrics for communication to senior leadership and cross-functional business partners.
• 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.
• Manages ongoing medical communication with HCPs, including documented medical review response and medical justification as applicable.
• Manages the provision of drugs through Patient Assistance Program mechanized by Medical Sciences.
• 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.
• 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.
• Supports the development and execution of patient request adjudication criteria in collaboration with the functional area Director and Scientific Advisor and TA Medical Directors.

Relevant knowledge and experience

• University Degree: PharmD, MD or PhD preferred. Bachelors degrees with relevant work experience may be considered
• Required Years of Related Experience: 5+ years of experience in pharmaceutical or health care relevant environment

Required Knowledge, Skills, And Abilities

• Advanced planning, organizational and time management skills with the ability to prioritize workflow to meet tight deadlines
• Strong proficiency in Microsoft Office (Word, Excel, PowerPoint), Adobe, SharePoint.
• Superior level of attention to details
• Strong understanding of regulations and compliance requirements
• Experience in drafting, revising, and implementing SOPs, including the management of review timelines, and coordination of document review comments.
• Development and communication of quality-based metrics in a regulated environment.
• Extensive experience or medical related product knowledge in different therapeutic areas, Process Excellence and/or process mapping including automation of processes.

Working Conditions

• Travel, on occasional basis (0-5%)
• Head office in Toronto

Primary Location

NA-CA-Ontario-Toronto

Organization

Janssen Inc. (7710)

Travel

Yes, 10 % of the Time

Job Function

Medical Affairs

Job Qualifications

Job Knowledge Requirements: