Medical Director, Patient Assistance and Special Access Programs

The Medical Director, Patient Assistance and Special Access Programmes will lead the medical involvement in these programs, including oversight of procedural document (SOP/Work Instruction) development and continuous process improvement. The Medical Director will be responsible for the definition and execution of patient request adjudication criteria in collaboration with the TA Medical Directors and in accordance with defined strategy, metrics & reporting to senior leaders, and communications with HCPs as required. The Medical Director will work closely with the TA Medical Directors and cross-functional partners regarding strategic planning for their areas of responsibility. He/she will also identify trends and opportunities and make recommendations for process changes to maximize efficiencies. He/she will be a key contact for global leaders and operating company colleagues in other countries, ensuring local processes are aligned with local regulations/compliance, global priorities and sharing best practices. The Medical Director will manage a team with direct reports including a Scientific Advisor and Project Manager.

Oversight of 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. Collaborate with key business partners (e.g. TA Medical Directors, BioAdvance) and global colleagues.

Functional accountability for the medical science strategy and processes for Janssen Canada’s Special Access Programme (pre-NOC) including owning the relevant SOP and related documents (including archiving) and collaborating with key business partners.

Finalization (in close collaboration with TA Medical Directors), continuous refinement, and implementation/execution of medical adjudication criteria for requests for Patient Assistance or Special Access to medicines. Communication of decisions and responding to HCP requests for clarification when required and as appropriate.

Development and tracking of dashboard metrics for regular review with the TA Medical Director, senior leaders and cross-functional partners (as appropriate) and ensuring audit-readiness of this data and all related documentation.

Training of appropriate members of medical affairs, BioAdvance, etc, to ensure compliance with SOPs and associated processes.

Line management and coaching of direct reports (Scientific Advisor and Project Manager).

Qualifications

MD preferred (PhD/PharmD and significant relevant experience could be considered)

Minimum of 3-5 years of relevant medical affairs pharmaceutical experience, strong clinical and/or scientific background and track record of collaboration in a matrix environment.

Experience leading complex projects and managing deliverables to plan

Resourcefulness

Experience in drafting, revising, and implementing SOPs, including the management of review timelines, and coordination of document review

Development and communication of quality-based metrics in a regulated environment.

Ability to make difficult/complex decisions, under pressure and in a timely fashion

Strength in communication to senior leaders and the healthcare community

Strong proficiency in Microsoft Office (Word, Excel, PowerPoint), Adobe, SharePoint

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Primary Location

Canada-Ontario-Toronto-19 Green Belt Drive

Organization

Janssen Inc. (7710)

Job Function

R&D

Requisition ID

2105934986W