Introduction
We are currently hiring a Clinical and Medical Affairs Manager for our client located in Toronto, ON. Our client is a Canadian company that specializes in the research, development, and manufacturing of dermal fillers. They focus on innovative solutions for the medical aesthetics market and are recognized globally for their high-quality products.
The Clinical and Medical Affairs Manager will be responsible for ensuring compliance with regulations (SOPs, GCPs, FDA, Health Canada), managing clinical trials, and evaluating investigational sites in North America. Additionally, maintain the Trial Master File, collaborate with vendors for medical writing and data management, secure IRB approvals, and manage study budgets. The position also supports business development through relationship-building with clinicians and investigators and participates in medical affairs activities such as training sessions, continuing medical education events, and advisory boards.
Responsibilities
- Ensure full compliance with all appropriate regulations: SOPs, GCPs, FDA, and Health Canada regulations.
- Assist in the planning, management, and execution of clinical trials.
- Help identify and evaluate investigational sites in North America.
- In collaboration with external vendors, assist in building, organizing, and maintaining the Trial Master File throughout the study.
- Collaborate with vendors for Medical Writing, Medical Monitoring, Data Management, and Statistics, as required.
- Help with planning and management of study budgets.
- Secure IRB study approvals and help with sites' IRB submissions and approvals.
- Support business development efforts by building and maintaining relationships with industry professionals, clinicians, and investigators.
- Collaborate and support North American medical affairs activities, such as training sessions, advisory boards, CME events, presentations, etc.
- Occasional travel may be required.
Experience
- University degree or Masters (scientific).
- Minimum 3-5 years of experience in clinical and medical affairs management in the pharmaceutical or medical device industry.
- Excellent written and oral communication skills.
- Bilingual (English and French) would be preferred (but not officially required).
- Track record of completed clinical trials, from conception to publication (drugs and/or medical devices).
- Experience in medical affairs activities, such as advisory boards, IITs (Investigator-Initiated Trials), educational programs development, etc.
What We Offer
Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.