Kelly, in partnership with Johnson & Johnson, is hiring a Medical Assessment Specialist
Description:
The Medical Assessment Specialist manages end-to-end medical assessment processes and facilitates the provision of medications through Special Access Programs, Medical Sciences-managed Patient Assistance Programs, and Patient Support Programs. The role encompasses all related activities, including records management.
Key responsibilities include, but are not limited to:
- Conducts and documents criteria-based scientific and medical assessments of requests from healthcare professionals (HCPs) for patient treatment support, in alignment with established internal processes. This includes, but is not limited to:
- Reviewing and assessing off-label treatment requests
- Evaluating the supporting clinical evidence and medical rationale
- Documenting recommendations for approval or rejection, together with the supporting rationale
- Maintaining documentation that supports governance, compliance, and audit readiness
- Escalating complex cases for Medical Affairs review
- Supports medical and coordination activities for Special Access Programs (SAPs), including communications with Health Canada and other internal and external business partners.
- Coordinates the provision of medications through designated system platforms and in collaboration with the relevant partner groups.
- Manages ongoing medical communications related to documented scientific evaluations with internal and external partners, as required and in accordance with established internal processes.
- Complies with drug safety and product quality reporting requirements, as well as all applicable regulatory and procedural obligations.
Required Skills and Experience:
- University degree in pharmacy. Other degrees may be considered for candidates with significant relevant experience.
- Minimum of 8 years of experience in the pharmaceutical industry or a relevant healthcare setting.
- Extensive pharmaceutical or clinical experience, with medical product knowledge across multiple therapeutic areas, together with experience in process excellence, process mapping, and process automation.
- Strong understanding of applicable regulatory and compliance requirements.
- Exceptional attention to detail.
- Advanced planning, organizational, and time-management skills, with the ability to prioritize work and meet tight deadlines.
- Advanced proficiency in Microsoft Office applications (Word, Excel, and PowerPoint), Adobe Acrobat, and SharePoint.
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📌 Medical Information Specialist (Toronto)
🏢 Kelly
📍 Toronto