Manager, Material Review

Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.

When choosing your career path, choose to be remarkable.

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, vision care, virology, women’s health , and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Role:

Act as the medical and regulatory review subject matter expert, and supervise the team of Specialists, Material Review.

Key Responsibilities:

• Review and evaluate the Canadian regulatory drug advertising environment. Stay current with knowledge of industry best practices, medical and regulatory requirements, codes of ethic, pre-clearance agencies.

• Under the lead of the Head Medical Operations and Excellence, implement risk management strategies for medical review activities in Canada.
• Supervise, evaluate, provide training and feedback to Specialists, Medical Review, and develop staff to expand their skills and knowledge in core job activities. That is:
  • Lead the performance oversight of the Specialists, Medical Review.
  • Spearhead the compliant medical review activities, ongoing training, quality checks and develop work instructions for the Specialists.

• • Ensure departmental training and compliance with established regulations, guidance’s and SOPs related to regulations for self and direct reports. Maintain audit readiness.

• In assigned therapeutic area(s), perform the review of both promotional and non-promotional material on AbbVie’s products and their related disease states.
• Provide opinion on project feasibility in consideration of Canadian regulations on drug advertising.
• Develop internal tools, such as but not limited to review grids, internal guidelines to ensure team alignment in the conduct of Material reviews.
• Conduct monthly reporting of volume and nature of Material reviewed by the team, or any other applicable measures.