Manager, Material Review

Overview

Abb Vie 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, and eye care — and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

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

• Review and evaluate the Canadian regulatory drug advertising environment. Stay current with knowledge of industry best practices, medical and regulatory requirements, codes of ethics, 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 Abb Vie 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.

Education / Experience required:

• Pharmacy or Life Sciences (i.e., Pharmacology major) Degree.
• Relevant experience with solid knowledge of the biotech/pharmaceutical industry.
  • Previous related experience and proven track record in similar role (minimum of three to five years).
  • Experience with in the pharmaceutical industry within the area of Regulatory/Medical Affairs, including experience in the review of promotional/non-promotional material desirable.
• Solid understanding of Canadian regulations regarding drug advertising, having had direct responsibility in this area.

Essential skills and abilities:

• Outstanding communication skills (oral and written), bilingualism preferred.
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.).
• Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks).
  • Work understanding of Veeva Promo Mats or similar promotional materials reviews system desirable.

• Ability to take key actions and demonstrate behavioural anchors that support all Abb Vie leadership competencies.
• Collaborates and communicates effectively through all levels of management across multiple divisions and functions. Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and promotion. Apply novel and creative methods to problem solving.
• BALANCES business needs and risk assessments with decision-making abilities.
• Effectively presents pertinent information to appropriate cross-functional groups. Effectively delivers difficult messages to multiple commercial stakeholders in the organization without damage to relationships. Aptitude to apply novel approach to problem solving while maintaining compliance and regulatory requirements.
• High work ethic standards.
• Strong communication skills, with the ability to evaluate, assess and synthesize scientific and clinical literature.
• Team player that is self-driven and proactive.
• Efficient negotiating skills, diplomacy, and tact; excellent ethics and integrity.
• High adaptability in coping with short timelines and shifting priorities.

This role requires minimum 3 days in office per week.

Travel:
Yes, 10%

Abb Vie aims to offer a French-speaking workplace in Quebec and has made efforts to limit English requirements. However, advanced English skills are essential for this role because the position involves working with English-speaking employees, clients, and regions outside Quebec.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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