Medical Affairs Specialist (Medical)

TL;DR

Medical Affairs Specialist (Clinical Research): Providing scientific support and medical oversight for clinical trials and early access programs with an accent on protocol adherence and participant safety. Focus on managing investigator relations, performing causality assessments for adverse events, and developing study documentation.

Location: Remote, Canada

Company

hirify.global is a mission-driven organization specializing in advancing clinical research and providing early access to medicines globally.

What you will do

• Act as the primary medical contact for investigators and regulatory bodies to clarify study protocols.
• Oversee clinical trials and Expanded Access Programs (EAP) to ensure participant safety and data integrity.
• Evaluate investigator sites during selection and feasibility processes to determine suitability.
• Lead investigator calls and meetings to optimize patient recruitment and ensure protocol adherence.
• Review adverse events (AEs/SAEs) and perform causality assessments for safety reporting.
• Develop study documents, including protocols and treatment guidelines, ensuring scientific rigor.

Requirements

• Bachelor's degree in health-related science or healthcare credentials (RN, PharmD, MD); advanced degree preferred.
• Minimum 5+ years of relevant clinical research experience, preferably in medical monitoring.
• Must be based in Canada.
• Willingness and ability to travel domestically and internationally for business meetings and industry events.
• Proven experience in protocol development, implementation, and safety monitoring.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).

Nice to have

• Experience in EAP, CUP, or NPP.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance, including FSA and HSA.
• 401K safe harbor plan with company match.
• Paid vacation, holiday, sick time, and parental leave.
• Commitment to diversity, equity, and inclusion (DEI) values.
• Supportive environment focused on wellness, growth, and professional development.