Senior Regional Medical Advisor French Speaking

Position Summary
Under the direction of the Country Medical Director, this position is responsible for developing and delivering a full range of Medical Affairs activities in Canada. The successful candidate will have already gained an excellent working knowledge and be able to provide examples of best practice in Medical Affairs. They will demonstrate the ability to take responsibility for delivering key medical affairs activities;

including but not limited to running advisory boards, producing medical materials and medical education initiatives, delivering training, scientific symposia, publication work, maintaining a network of medical thought leaders. Where appropriate they will take a leading collaborative role in delivering health technology assessment submissions.

He / she will provide technical scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and Country rules and regulations. They will have a strong scientific / medical background and be able to converse at all levels.

Provide support to the Country Medical Director in developing and implementing Medical Affairs’ initiatives to support the needs of the Affiliate including, but not limited to:

• Develop and maintain excellent thought leader relationships across the country in the field of rare disease specifically Fabry Disease and Pompe Disease (requiring national travel)
• Take accountability for the development, oversight and execution of the medical plan in partnership with the Country Medical Director
• Support the Medical Director with the execution of the Medical Affairs strategy and support country marketing activities for all Amicus products, ensuring adherence to all Amicus policies and procedures as well as local regulatory, legal and compliance requirements.
• Provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Clinical Trials (CT’s) and Clinical Development support as needed.
• Develop & deliver Health Technology Assessment submissions working in partnership with market access colleagues where required. Provide support to cross functional team members developing local programs and materials
• Compliance with all company and local regulations, alignment with local Code of Conduct, including adverse events, product complaints and pregnancy reports according to company procedures

In addition to the above the role will be responsible for:

• Thought Leader Engagement (70%)
  • Develop and maintain excellent thought leader relationships in conjunction with the broader country team
  • Support the delivery of Advisory Boards
  • Regularly attend events such as scientific meetings, conferences/symposia to interact with thought leaders and enhance disease area knowledge whilst also ensuring high quality feedback is provided in a timely manner to relevant colleagues
• Medical Information and Communication (10%)
  • Supports Medical Information enquiry handling process and advises on medical safety or clinical issues as required
  • Support congress medical information activities
  • Provide literature analysis for Key Account Managers (KAMs), marketing, and customers
  • Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the Country for completeness, consistency and reporting requirements
• Medical oversight and review of promotional and non-promotional activities (5%)
  • Applies good working knowledge of IMC Code of Ethical Practices and Amicus Standard Operating Procedures (SOP) and advises on compliance issues and review promotional materials and activities
  • Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards
• Medical Training (10%)
  • Create and deliver effective Medical training and clinical updates
  • Develop slide decks for training activities and for the support of key customers
  • Demonstrate expert knowledge of Amicus’ and competitor products and activities
• Clinical Trial activity (5%)
  • Contribute to the management of…