Senior Regional Medical Advisor, Nordics Location Denmark Requisition ID 2261 # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1306) Job Brief Senior Regional Medical Advisor, Nordics 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 role can also be based from Sweden or Denmark*** 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 all Nordic countries Roles and Responsibilities: 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: · 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 · Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease and Pompe Disease in the Nordic countries. · They will provide technical scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and Nordic countries rules and regulations. · 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. In addition to the above the role will be responsible for: Note: the following percentages are an approximate guide to the allocation of time in each activity · Thought Leader Engagement (50%) · Develop and maintain excellent thought leader relationships in conjunction with the broader country team · Organize and run country/Nordic 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 · Organise and run high quality medical education meetings & initiatives · Support Amicus’ vision and goals through regular meetings with physicians and other key customers · 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 safety reports and product complaints 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 (15%) · Applies good working knowledge of country [LIF, ENLI, Reklameregler, PIF, Frumtok] Codes of Practice 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 · Support country Medical Director in CRM medical approval of promotional and non-promotional material · 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 (15%) · Contribute 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 · Demonstrate a good knowledge in project management, internal processes and Good Clinical Practice (GCP) and contribute to the operational activities of local clinical trials (ph IV, RWD/Epidemiology) Educational Requirements · Advanced post graduate scientific degree or health care professional ( MSc, MD, PhD) Professional Work Experience Requirements · Prior relevant experience as a medical advisor · They will have a have a strong scientific / medical background and be able to converse all levels · Pharmaceutical or Biotech industry experience preferred · Excellent knowledge of appropriate national regulatory guidelines, e.g. Medicines Act and the Human Medicines Regulations, Nordic Country specific Code of Practice and Standard Operating Procedures, combined with their implementation within the business environment · Proven knowledge of medical affairs activities including clinical trial design, management, analysis and reporting, including GCP · Material review experience for longer than 12 months ideally as Final Signatory for both promotional and non-promotional material · Medical expertise in the relevant therapeutic areas. Experience in rare diseases would be an advantage – ideally in lysosomal disorders. · If a Healthcare professional, 2-4 years’ clinical experience Experience and Skills · Must possess a good understanding of the healthcare environment within their country/region 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 · Fluent in local language and in written and spoken English Other skills/Attributes · Demonstrated alignment with Amicus Mission Focus Behaviors · Passion for rare disease and patient focused · Good team player Travel · Willingness to travel (nationally and internationally) at least 30% 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, color, 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. #Li-Remote