Senior Regional Medical Advisor - Canada (French Speaking)

Amicus Therapeutics, Inc.; Quebec; Hybrid; CAD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Medical Affairs professional to lead initiatives in Canada, focusing on rare diseases such as Fabry and Pompe. This role involves developing relationships with thought leaders, executing medical plans, and ensuring compliance with regulations. The ideal candidate will have a strong scientific background, excellent communication skills, and a passion for improving patient outcomes. Join a dynamic team that values diversity and innovation, where your contributions will play a crucial role in advancing healthcare solutions. If you are driven and ready to make a difference, this opportunity is for you.

Qualifications

• Significant experience in medical affairs within the pharmaceutical or biotech industry.
• Strong knowledge of regulatory guidelines and ethical practices.

Responsibilities

• Develop and maintain relationships with thought leaders in rare diseases.
• Support the execution of Medical Affairs strategy and marketing activities.
• Provide operational support for Medical Information and Clinical Trials.

Skills

Medical Affairs

Clinical Trial Management

Regulatory Compliance

Interpersonal Skills

Bilingual (French/English)

Organizational Skills

Problem Solving

Education

Advanced Post Graduate Scientific Degree

Healthcare Professional

Job description

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 be 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.

ROLES AND RESPONSIBILITIES

1. 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:
2. 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)
3. Take accountability for the development, oversight and execution of the medical plan in partnership with the Country Medical Director
4. 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.
5. 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.
6. 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
7. 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:

1. Thought Leader Engagement (70%)
2. Develop and maintain excellent thought leader relationships in conjunction with the broader country team
3. Support the delivery of Advisory Boards
4. 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
5. Organise and run high quality medical education meetings & initiatives
6. Support Amicus’ vision and goals through regular meetings with physicians and other key customers
7. Medical Information and Communication (10%)
8. Supports Medical Information enquiry handling process and advises on medical safety or clinical issues as required
9. Support congress medical information activities
10. Provide literature analysis for Key Account Managers (KAMs), marketing, and customers
11. 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
12. Medical oversight and review of promotional and non-promotional activities (5%)
13. 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
14. Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards
15. Medical Training (10%)
16. Create and deliver effective Medical training and clinical updates
17. Develop slide decks for training activities and for the support of key customers
18. Demonstrate expert knowledge of Amicus’ and competitor products and activities
19. Clinical Trial activity (5%)
20. Contribute to the management of Investigator Initiated Studies (IIS)
21. Contribute to the selection of potential study sites for development trials
22. Provide strategic input into the development and execution of local clinical trials, IIS activities and publication plans

Educational Requirements

• Advanced post graduate scientific degree or health care professional

Professional Work Experience

• Significant prior experience in medical affairs
• Pharmaceutical or Biotech industry experience
• Excellent knowledge of appropriate national regulatory guidelines, IMC Code of Ethical Practices, combined their implementation within the business environment.
• Proven knowledge of medical affairs activities including clinical trial design, management, analysis and reporting, including GCP.
• Medical expertise in the relevant therapeutic area
• Experience in rare diseases would be an advantage – ideally in lysosomal disorders.
• If a Healthcare professional, able to demonstrate relevant clinical experience
• Must possess a good understanding of the healthcare environment within their country of responsibility
• Experience in supporting clinical studies (phase III- IV, registries, investigator-initiated studies)
• Strong organisational, problem solving, and able to collaborate and work effectively cross functional working skills
• Customer focus & a timely results orientated approach to their role
• Excellent interpersonal & team working skills
• Excellent Project and time management skills
• Sociable, confident and outgoing
• Bilingual in French / English required

Location

• Home/field based ideally based in Quebec
• Willingness to travel (nationally and internationally) at least 50% time

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, colour, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.