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 environment.
- 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.
Preferred Skills and Experience:
