Material Review Specialist

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X and  YouTube.

Job Description

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.

We have a new opportunity for a Specialist, Material Review to join our Material Review team. In this role, the Specialist is responsible for the medical/regulatory review and approval of promotional and non-promotional materials. 

Role:

• Conduct a high-quality review of all promotional and non-promotional materials and activities according to internal SOPs, relevant Industry Codes and external laws and regulations. The incumbent will also provide training and advice to internal stakeholders on medical review processes, codes of practice and regulations.
• This role reports directly to the Manager, Material Review within the Medical Excellence/Medical Operations Department.

Key Responsibilities:

• In assigned therapeutic area(s) (TA), perform the review of both Promotional and Non-Promotional Material on AbbVie’s products and their related disease states.
  • Review the Material to ensure medical and scientific accuracy and adherence to applicable regulations, codes, and internal requirements.
  • Collaborate closely with internal stakeholders.
• Stay current with knowledge of industry best practices, medical and regulatory requirements, Codes of Ethic/Practice, Preclearance Agencies.
• Provide guidance on project feasibility in consideration of Canadian regulations on health product advertising.
• Support the generation and presentation of metrics reports on medical review in designated TAs.

Qualifications

Education / Experience required:

• Pharmacy or Life Sciences (i.e., Pharmacology) Degree. 
• Relevant experience with solid knowledge of the biotech/pharmaceutical industry.
  • Previous related experience and proven track record in similar role (minimum of two to three years)
  • Experience within the pharmaceutical industry within the area of Regulatory/Medical Affairs, including experience in the review of promotional/non-promotional material and product training would be advantageous. 
• Excellent knowledge of Canadian regulations regarding health product advertising.

Essential skills and abilities:

• Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks).
  • Working understanding of Veeva Vault or similar review system desirable.

Key leadership competencies:

• Ability to take key actions and demonstrate behavioural anchors that support all AbbVie leadership competencies.
• Extensive scientific and/or clinical knowledge
• Excellent critical judgment and fast learner.
• Team player, self-driven and proactive.
• Efficient negotiating skills, diplomacy, and tact; excellent ethics and integrity.
• High adaptability in coping with short timelines and shifting priorities.

AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement, advanced amount of knowledge of English / Fluency in English is an essential requirement for the position of Specialist, Material Review including, but not limited to, for the following reasons:

• English speaking employees outside the province of Quebec.
• English speaking clients outside the province of Quebec
• All materials to revise are in English  

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

Additional Information

AbbVie 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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