Senior Regional Medical Advisor

Job summary
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.This position is accountable for developing and delivering a full range of Medical Affairs activities.The successful candidate will have already gained an excellent working knowledge and be able to provide examples of best practice in Medical Affairs.
Job seniority: mid-to-senior level
Responsibilities
• Develop and maintain excellent thought leader relationships in the field of rare disease• Take accountability for the development, oversight and execution of the medical plan• Lead on medical initiatives fully independently and with minimal support• Support the Medical Director with the execution of the Medical Affairs strategy• Provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Clinical Trials (CTs) and Clinical Development support• Provide medical leadership in obtaining health technology approvals for Amicus products• Act as a leader within the country cross functional team• Thought Leader Engagement• Delivery of Advisory Boards• Organize and run medical education meetings & initiatives• Support Amicus’ vision and goals through regular meetings with physicians and other key customers• Medical Information and Communication• Supports Medical Information enquiry handling process• Support congress medical information activities• Provide literature analysis for Key Account Managers (KAMs), marketing, and customers• Medical oversight and review of promotional activities• Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards• Ensure activities are aligned to company strategy• Assist medical director to ensure medical governance within the affiliate• Medical Training• Medical training and clinical updates• Develop slide decks for training activities and for the support of key customers• Develop expert knowledge of Amicus’ and competitor products and activities• Clinical Trial activity• Contribution to the management of Investigator Initiated Studies (IIS)• Contribute to the selection of potential study sites for development trials• Provide strategic input into the development and execution of local clinical trials, IIS activities and publication plans
Requirements
• Advanced post graduate scientific degree or health care professional• Prior relevant experience as a Medical Advisor• Pharmaceutical or Biotech industry experience preferred• Knowledge of national regulatory guidelines• Proven knowledge of medical affairs including clinical trial design, management, analysis and reporting• Medical expertise ideally in lysosomal disorders• Experience in rare diseases would be an advantage• Experience in supporting clinical studies• Organizational, problem solving & collaborate cross functional working skills• Customer focus & timely results orientation approach• Excellent interpersonal & team working skills• Project and time management skills• Sociable, confident and outgoing• Fluent in written and spoken English• Willingness to travel• 60% field/40% office
Key Skills Needed
• Excellent interpersonal skills• Strong leadership abilities• Proficient in compliance• Scientific and medical background• Good understanding of the healthcare environment